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PILOT STUDY REPORT
BRIGHTWAVES
Denis Boucher, Ph.D.
November 20, 2000
_________________________________1100, boul. de la Rive-Sud, suite 120St-Romuald (Quebec) G6W 5M6Tel.: 418-834-1177 Fax : 418-834-5596 Table of Contents
1. Introduction . 1
2. Methodology. 1
2.1 The subjects. 12.2 Progress of the Pilot Study . 22.3 Selection Criteria. 22.4 Measurements. 3 A) The Sleep Diary. 3B) Sleep Impairment Index (SII). 3C) Beliefs and Attitudes About Sleep (BAS). 4D) Pittsburgh Sleep Quality Index (PSQI) . 4 3. Description of the Results . 4
3.1 The subjects. 53.2 Medication taken . 53.3 Sleep diary. 5 3.3.1 Total nap time. 53.3.2 Time period between going to bed and turning out the lights. 63.3.3 Time period between the last awakening and rising . 63.3.4 Sleep- onset time . 73.3.5 Number of sleep interruptions. 73.3.6 Duration of sleep interruptions. 83.3.7 Sleep duration. 83.3.8 Feeling rested upon rising . 93.3.9 Sleep evaluation . 9 3.4 Sleep Impairment Index . 103.5 Dysfunctional Beliefs and Attitudes about Sleep. 103.6 Pittsburgh Sleep Quality Index (PSQI) . 11 4. Interpretation of the results. 12
5. REFERENCES . 14
Tableaux
Table 1 Medication taken . 5
Table 2 Means and standard deviations of total naptime . 6
Table 3 Means and standard deviations of the time period before turning out the lights . 6
Table 4 Means and standard deviations of the time period between the last awakening and
Tableau 5 Feeling rested upon rising . 9
Table6 Means and standard deviations for sleep evaluation. 10
Table 7 Means and standard deviations for the Sleep Impairment Index . 10
Figures
Figure 1 Evolution of sleep-onset time. 7
Figure 2 Number of sleep interruptions per night. 8
Figure 3 Duration of sleep interruptions per night . 8
Figure 4 Duration of a night's sleep. 9
Figure 5 Evolution of subjects' beliefs and attitudes . 11
Figure 6 Perceived evolution of sleep quality . 12
1. Introduction
Midi-Plus Consultants Inc. gave our company, Whittom & Boucher Promotion de la Santéinc., the mandate to develop a research protocol with the objective of evaluating the influenceof BrightWaves - a process generating infra sounds that correspond to brain waves - on thesleep quality of people with sleep disorders.
Midi-Plus Consultants Inc. first used the protocol in the framework of a pilot study. Thepersonnel of Midi-Plus Consultants directed the collection of data for this pilot study and ourcompany acted as advisors throughout the study. Whittom & Boucher Promotion de la SantéInc. also carried out a statistical analysis of the collected data and wrote the present report.
It is also important to emphasize that in order to respect the intellectual property of our client,we cannot divulge the nature of the product, BrightWaves, in detail in this report.
1.1 Objectives of the pilot study
This pilot study consisted of two objectives: 1) To evaluate the influence of BrightWaves on the sleep quality of people with sleep 2) To determine if it would be useful to proceed with an experimental study of this 2. Methodology
2.1 The
subjects
The subjects were recruited through an advertisement, which appeared in the Journal deQuebec on May 22, 2000, and a through a television report on the program «Vision Québec»on TQS.
Thirty-four people in all (16 men and 18 women) showed an interest in participating in thestudy by contacting the Midi-Plus Consultants inc. team. All of these people were acceptedand became part of the study. Three people (three women) dropped out of the study before theexperimental phase began. One of them had not been able to obtain a CD player, anothermoved without informing the Midi-Plus Consultants team, and one person found theprocedure too complex.
Therefore, thirty people began the study; however, five people (four men and one woman)abandoned the study during the pretest phase. Three of them did not return any of thedocuments and two people had variable schedules (day, evening and night), making itimpossible for them to follow the required procedure. Also, six people (four men and twowomen) withdrew as soon as the treatment phase began. Two of these people mentioned thatthey were too busy to complete the study, one person stated problems with his sound system,one person had an accident, one person withdrew because of illness and one person withdrew following the death of a loved one. Finally, one person's (a woman's) data was sent by mail asrequested, but did not reach the Midi-Plus Consultants team.
Thus, the analysis of the data was based on 19 subjects (8 men and 11 women). The subjectswere not remunerated for participating in this study.
2.2 Progress of the Pilot Study
The study took place from May 25 to mid-July of the year 2000. Following the advertisementfor the study, the people who called the Midi-Plus Consultants team were given informationon the study at the time of this first contact by telephone.
Subsequently, a package was sent to each subject, containing information and documentsrelated to the pre-test phase such as: a letter explaining the procedure to follow, an agreementof non-disclosure, a consent form, a general information form, a pre-stamped envelope,questionnaires related to the evaluation of sleep quality and sleep problems, and the sleepdiary. The sleep diary covered a two-week period. The subjects were asked to fill out andreturn the group of documents as soon as possible, with the exception of the sleep diary, usingthe pre-stamped envelope provided in the package. In the days preceding the end of the two-week pre-test period corresponding to the sleep diary, the subjects received a new packagecontaining: a new sleep diary, the CD BrightWaves, a letter explaining the procedure tofollow (in which the subjects were invited to return their first sleep diary as soon as possible),as well as a pre-stamped envelope. The subjects were asked to use the compact disc for aperiod of one month, following the instructions provided with the CD. A few days before theend of the treatment phase, the subjects received a final package, which included thequestionnaires to fill out, a letter explaining the procedure to follow and a pre-stampedenvelope in which to return the documents.
The pre-test period lasted for two weeks. From the beginning, the subjects were asked to fillout the following questionnaires: Index of Sleep Quality, Beliefs and Attitudes about Sleep,and the Sleep Impairment Index. As well, for a period of two full weeks, the subjects wereasked to fill out their sleep diaries.
Once the pre-test period was completed, the experimental treatment phase began. Subjectswere to listen to the laser disc BrightWaves each night for the whole night for a period of onemonth. During this period, the subjects were to fill out their sleep diaries. At the end of theexperimental period, the subjects were asked to fill out the questionnaires again: SleepQuality Index, Beliefs and Attitudes about Sleep, and the Sleep Impairment Index.
For the duration of the pilot study, the experimenters had no voluntary contact with thesubjects, so as not to influence the results of the study. However, they had to remain availableto the subjects in order to answer their questions if necessary.
2.3 Selection
Criteria
No selection criteria were used for the purposes of this pilot study. Thus, the subjects wereaccepted independently of age, medical status, medications consumed and the perception ofthe product.
2.4 Measurements
With regard to this pilot study, the measurement instruments used were those most currentlyemployed in the study of sleep disorders. However, it must be noted that no physiologicalmeasurements were taken, nor were any diagnoses made regarding the nature of any sleepdisorders.
The Sleep Diary
Given the subjective nature of the experience of insomnia, the representation and thedescription of it by the person who lives through the experience are considered to be veryimportant measurements for evaluating the changes in sleep that occur over a specific periodof time. This instrument is presented in the form of a grid to fill out daily upon waking, and itprovides a subjective estimation of sleep parameters. A two-week basic data recording periodis suggested in order to obtain a valid and reliable profile of sleep problems and to minimizereactivity effects related to the self-evaluation method (Lacks & Morin, 1992). The gridallows the collection of the following information: 1) Nap,2) Medication,3) Bed time,4) Sleep onset time,5) Number of night awakenings,6) Duration of night awakenings,7) Wake time,8) Rise time,9) Physical state upon rising10) Sleep quality The form used was that of Morin (1997).
Sleep Impairment Index (SII)
This questionnaire is composed of 7 items which are used to evaluate quantitatively howmuch the person is affected by insomnia and to judge the results of a treatment (Morin &Azrin, 1985, cited in Mimeault, 1997). The subject responds to the questionnaire with the helpof a Likert-type scale (0=None to 4=Extreme) for the following components: 1) Severity of delayed sleep onset,2) Satisfaction with actual sleep,3) Interference of insomnia with daytime functioning ,4) Perception of the consequences of insomnia5) Level of distress caused by insomnia.
This information is significant in terms of the person's perception of his sleep difficulties.
The total score falls between 0 and 28, for which a high score indicates an elevated perceptionof the sleep impairment. The French version of the Sleep Impairment Index (Blais, Gendron,Mimeault & Morin, 1996, cited in Mimeault, 1997) offers good internal consistence with aCronbach alpha coefficient of 0.88 and a test-retest fidelity coefficient of 0.65 for a two-weekinterval.
Beliefs and Attitudes About Sleep (BAS)
This 30 statement questionnaire evaluates perceptions about sleep (Morin, 1993). Fivetheoretic constructions concerning strategies favoring sleep are studied: 1) Attribution error and amplification of the consequences of insomnia,2) Control and predictability of sleep,3) Unrealistic expectations about sleep requirements,4) Preconceived ideas about the causes of sleep and5) Mistaken concepts on ways of promoting sleep.
For each statement, the person evaluates how much he agrees or disagrees with the help of ananalogic scale (0=stongly disagree to 10= strongly agree). A high score on this questionnaireis associated with a high level of dysfunctional beliefs. The French version of the instrumentoffers very good internal consistence (0.90 alpha) and test-retest reliability of 0.72 for a two-week period.
Pittsburgh Sleep Quality Index (PSQI)
This index (Buysse, Reynolds, Monk, Berman & Kupfer, 1989, cited in Mimeault, 1997)evaluates the quality of sleep and its disturbances in the course of the past month. It consistsof 19 self-evaluation questions, measuring seven components: 1) Subjective sleep quality,2) Sleep latency,3) Sleep duration,4) Habitual sleep efficiency,5) Sleep disturbances,6) Use of sleeping medications,7) Daytime dysfunction.
The quotation takes place on a scale of 4 points (0 = no difficulty to 3 = severe difficulties).
The seven components of the score add up to give a score varying between 0 and 21 points.
A result of more than 5 indicates that the subject suffers from severe sleep difficulties for atleast two of the seven components or that he experiences moderate difficulties in more thanthree. The psychometric data of the French version demonstrates an acceptable internalhomogeneity (alpha = 0.88) and a test-retest reliability of 0.62 (Blais et al., 1996).
3. Description of the Results
1) To evaluate the influence of BrightWaves on the sleep quality of people with sleep 2) To determine if it would be useful to proceed with an experimental study of this 3.1 The
subjects
The analysis of the results was based on 19 subjects (8 men and 11 women) aged between 24and 74 years old, the average age being 45.1 years old (± 11.2).
3.2 Medication
taken
Eight people took medication during the progress of this study. Table 1 shows the number ofpeople using a particular medication during the pre-test period and during the period usingBrightWaves.
Medication taken
Medication taken
Number of people taking
Number of people taking
medication during the pre-test
medication during the
treatment phase
3.3 Sleep
diary
The different variables of the sleep diary were analyzed through a Student t-test or sign test,according to the norms of the test, thus comparing the results obtained in the pre-test phase tothose obtained after the last two weeks of the post-test phase (use of BrightWaves).
3.3.1 Total nap time
The results of the analyses demonstrated that the use of BrightWaves did not influence totalnaptime in a significant way (p > 0.05). Thus, naptime remained similar for all of the subjectsthroughout the experiment. Table 2 presents the means and standard deviations of totalnaptime.
Means and standard deviations of total naptime
Variable
Pre-test
Post-test
3.3.2 Time period between going to bed and turning out the lights
The analysis of the results based on the period of time between going to bed and turning outthe lights revealed the use of BrightWaves brought about no significant change (p > 0.05) inthis respect. Table 3 presents the means and standard deviations of the time periods beforeturning out the lights in the pre-test and post-test phases.
Means and standard deviations of the time period before turning out the
lights
Variable
Pre-test
Post-test
3.3.3 Time period between the last awakening and rising
The results of the analyses on the time period between the last awakening and rising did notallow the demonstration of a significant influence (p > 0.05) after the use of BrightWaves. So,the time period between the last awakening and rising remained unchanged. To this effect,Table 4 presents the means and standard deviations of the pre-test and post-test results for thisvariable.
Means and standard deviations of the time period between the last
awakening and rising
Variable
Pre-test
Post-test
3.3.4 Sleep- onset time
The results of the analysis based on sleep-onset time demonstrated that after usingBrightWaves, the subjects reported taking less time to fall asleep, thus going from an averagefalling asleep period of 27.95 (±21.80) minutes in the pre-test phase to 14.93 (±9.02) minutes in the post-test phase (p < 0.002). This represents a significant decrease of 46.6% in sleep-onset time. Figure 1 presents the evolution of sleep onset time in the pretest and post-testphases.
Evolution of sleep-onset time
Sleep-onset time (h.mm)
3.3.5 Number of sleep interruptions
The analysis of the results related to the number of sleep interruptions revealed that the use ofBrightWaves produced a significant decrease (p < 0.03) of the number of sleep interruptionsper night, thus going from 1.68 (±0.89) interruption before using BrightWaves to 1.31 (±0.91) interruption after using it. This corresponds to a reduction in sleep interruptions in the order of22%. Figure 2 presents the evolution of this variable over time.
Number of sleep interruptions per night
Number of sleep interruptions per night
3.3.6 Duration of sleep interruptions
The analysis of the results also showed a significant decrease (p < 0.002) in the duration ofsleep interruptions per night after using BrightWaves. The duration of the interruptions wentfrom an average of 28.32 (±21.69) minutes before the use of BrightWaves (pre-test phase) to an average of 16.46 (±13.36) minutes following its use, corresponding to a decrease of close to 42%. Figure 3 shows the evolution of the duration of sleep interruptions over time.
Duration of sleep interruptions per night
Duration of sleep interruptions
3.3.7 Sleep duration
The analysis of the results based on the duration of a night's sleep revealed a significantimprovement (p < 0.03) in the amount of sleep per night following the use of BrightWaves,going from 7.14 (± 1.09) hours per night in the pre-test phase to 7.59 (±1.16) hours per night.
This represents and improvement of 6.3% for sleep duration. Figure 4 shows the changeobserved in the duration of a night's sleep.
Duration of a night's sleep
Duration of a night's sleep
3.3.8 Feeling rested upon rising
According to a Likert-type scale ranging from 1 (exhausted) to 5 (rested), the subjectsevaluated how rested they felt upon rising. The analysis of the results demonstrated asignificant improvement (p < 0.002) in the feeling of being rested upon rising, going from anaverage of 2.94 in the pre-test phase to 3.30 in the post-test phase, which corresponds to a12.2% improvement. Table 5 shows the means and standard deviations of the feeling of beingrested upon rising in the pre-test and post-test phases.
Tableau 5
Feeling rested upon rising
Variable
Pre-test
Post-test
3.3.9 Sleep evaluation
The subjects' evaluation of their own sleep was made by means of a Likert-type scale rangingfrom 1 (very agitated) to 5(very deep). The analysis of the results showed a significantimprovement in terms of the perception of the preceding night's depth of sleep. This valuewent from 3.10 in the pre-test phase to 3.41 following the use of BrightWaves, thus corresponding to an improvement of 10%. Table 6 shows the means and standard deviationsfor this variable for the pre-test and post-test phases.
Means and standard deviations for sleep evaluation
Variable
Pre-test
Post-test
3.4 Sleep
Impairment
Index
The analysis of the results obtained from the questionnaire Sleep Impairment Index wereanalyzed by means of a Student t-test (paired sample), comparing the pre-test results withthose obtained in the post-test phase, after the use of BrightWaves. The analysis of the resultsrevealed a tendency for change (p = 0.057) in terms of the perception of sleep imapirmentafter the treatment phase. However, this change cannot be considered a significantimprovement. Having a greater number of subjects may have allowed a significant change totake place. Table 6 shows the means and standard deviations of the results obtained in thepre-test and post-test.
Means and standard deviations for the Sleep Impairment Index
Variable
Pre-test
Post-test
3.5 Dysfunctional Beliefs and Attitudes about Sleep
The results obtained from the questionnaire, Beliefs and attitudes about sleep were analyzedby the means of a Student t-test (paired sample), once more comparing the results obtained inthe pre-test phase with those obtained in the post-test phase. The analysis of the resultsrevealed a significant improvement in the subjects' beliefs and attitudes about sleep (p<0.009). The use of BrightWaves thus gave rise to a positive change in terms of dysfunctionalbeliefs and attitudes, going from a score of 127 (±41.57) in pre-test to 108,2 (±38,93) in post- test, which represents an improvement of 14.8%. Figure 5 shows the evolution of the subjects'beliefs and attitudes over time.
Evolution of subjects' beliefs and attitudes
Beliefs and Attitudes
3.6 Pittsburgh Sleep Quality Index (PSQI)
The results of the questionnaire Pittsburgh Sleep Quality Index were analyzed through aStudent t-test (paired sample), comparing the results obtained in the pre-test phase to thoseobtained after the treatment phase. The analysis of the results demonstrated a significantimprovement in sleep quality (p < 0.04). These results highlight the fact that the subjectsnoted better sleep quality following the period using BrightWaves, going from an averagescore of 6.34 (±2.42) in pretest to 4.99 (±2.81) in post-test, thus implying an improvement of 21.3%. Figure 6 highlights the evolution of perceived sleep quality over time.
Perceived evolution of sleep quality
Pittsburgh Sleep Quality Index
4. Interpretation of the results
1) To evaluate the influence of BrightWaves on the sleep quality of people with sleep 2) To determine if it would be useful to proceed with an experimental study of this The results of this study showed that the use of BrightWaves did not influence the variables:total nap time, time between going to bed and turning out the lights and the time betweenwaking and rising, indicating that these sleep habits stayed the same throughout theexperiment.
However, the analyses demonstrated that the use of BrightWaves gave rise to a decrease inthe time it took to fall asleep, a decrease in the number of sleep interruptions and in theduration of these interruptions, an increase in sleep duration, an improvement in the feeling ofbeing rested upon waking and in the perception of a deeper sleep. Therefore, these resultsindicate that BrightWaves modified important aspects influencing sleep quality.
The use of BrightWaves also brought about a positive change in dysfunctional beliefs andattitudes subjects may have had in terms of sleep. Although BrightWaves does not act directlyon peoples' beliefs and attitudes, it is possible to consider that its influence on other sleepparameters has an indirect positive effect on these beliefs and attitudes. However, thishypothesis could only be confirmed through a clinical experimental study with the use of a control group. In addition, the use of BrightWaves seemed to bring about an improvedperception of sleep quality in the subjects.
However, the results demonstrated that despite a positive influence the use of BrightWaveshad on several of the preceding variables, the perception of sleep impairment was notmodified, even though a tendency for change must be noted. Therefore, this leaves room toconsider the fact that a longer exposure to BrightWaves and/or a greater number of subjectswould be necessary for the changes engendered by BrightWaves to bring about a modificationof perceived sleep impairment in the subjects.
In conclusion, the results demonstrated that BrightWaves positively influenced several sleepparameters, although it must be noted that certain parameters were not modified: total naptime, time between going to bed and turning out the lights, time between waking and risingand the ability to positively influence perceived sleep impairment. However, apart from thelatter, these variables do not seem to have as fundamental an influence as the variables thatwere positively modified following the use of BrightWaves.
¾ sleep-onset time;¾ number of sleep interruptions;¾ duration of the interruptions;¾ sleep duration;¾ feeling rested upon waking;¾ perception of a deeper sleep;¾ beliefs and attitudes;¾ sleep quality.
These results have therefore provided a response to the objectives of the study, thusdetermining that BrightWaves can positively influence certain important parameters affectingsleep quality and justifying the passage to the next step: an experimental study However, it must be specified that this pilot study has certain limitations. It does notconstitute an experimental research design with the presence of a control group and randomassignment of subjects. Because of this, it was impossible to control the placebo effect or tocompare the efficiency of BrightWaves with any other treatment. Moreover, it would beimportant during an experimental study to make a diagnosis and/or classification of theseverity of the sleep disorders affecting the subjects in order to determine, if there aresignificant changes, to what extent BrightWaves influences people suffering from severe andchronic disorders.
In addition, even though the use of BrightWaves gave rise to positive changes in terms ofseveral parameters influencing the quality of sleep, it is presently impossible to predict theclinical impact of BrightWaves. It must also be taken into account that no physiologicalvariables were evaluated. Therefore, it is impossible to know at this time if BrightWavesmodifies the brain waves of its subjects, thus acting according to the mechanism proposed byits creator.
This pilot study was, therefore, an essential step in determining the potential clinical impact ofBrightWaves. Since the results suggest a very interesting efficiency on the part of theproduct, it is now a matter of proceeding to an experimental study that will investigate notonly the psychological aspect, but also the physiological variables (brain waves) in order to confirm the effectiveness and the clinical interest of this product. This experimental study willcompare BrightWaves to a placebo treatment and, ideally, a placebo treatment and a knowntreatment. At that time, more precise and complete conclusions could be drawn.
5. REFERENCES
Lacks, P., & Morin, C.M. (1992). Recent advances in the assessment and treatment ofinsomnia. Journal of Consulting and Clinical Psychology, 60, 586-594.
Mimeault, V. (1997). Thérapie cognitivo-comportementale de l'insomnie : Bibliothérapie avecou sans contact professionnel. Mémoire de maîtrise. Université Laval, Québec.
Morin, C.M. (1997). Vaincre les ennemis du sommeil. Les Éditions de l'Homme.
Morin, C.M. (1993). Insomnia: Psychological Assessment and Management. New York:Guilford Press.

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