Effectiveness of Music Therapy on Sleep Disorders

Study Overview
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Brief Summary
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The purpose of this study is to determine whether listening to music before falling asleep can improve sleep quality in patients with sleep disorders.

Detailed Description
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Sleep is a key factor in a person's health, and we actually spend one third of our lives sleeping. The latest figures show a prevalence of insomnia in 20-30% of French adults. Sleep disorders are a growing public health concern. Treatment for insomnia is often some form of drugs; however, the side effects of these treatments (sedatives, hypnotics or anti-anxiety medications) are significant. Non drug-treatments like music therapy are growing in popularity. The objective of this study is to demonstrate the effectiveness of musical interventions on sleep disorders in general population. It is a prospective, multicentered, double-blind, randomized comparative intervention study, comparing 3 parallel patient groups. Patients included in this study will be selected by their physicians according to the severity of their disorders. Enrollment period will last for 2 months and the study will last 3 months. The primary outcome (score on Pittsburgh Sleep Quality Index, PSQI) is a discrete quantitative variable. The statistical tests used will concern the comparison of the average deltas of each group by using analysis of variance (ANOVA). The selected alpha risk, or Type 1 error, is 5%. The results expected in this study are a significant decrease in Pittsburgh scale scores in the music intervention group. The decrease in Pittsburgh scale scores should be compared to the results from this study: Qun Wang and Al; The Effects of Music Intervention on Sleep Quality in Community-Dwelling Elderly, The Journal of Alternative and Complementary Medicine, 2016. In this 3-month study, the average change compared to the baseline is 6.44 in the musical intervention group and 3.28 in the control group. The pooled standard deviation is estimated to be 3.53. Musical intervention is non-invasive, so it's a low-risk therapeutic tool for general practice that may be useful in the management of sleep disorders. Its effectiveness, if demonstrated, could lead to new recommendations for the treatment of sleep disorders, and reduce the use of medication such as sedatives and hypnotics.

Official Title
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A 3-months, Controlled and Double-blind Trial of the Effectiveness of Music Therapy in the Treatment of Sleep Disorders in General Medicine.

Conditions
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Sleep Disorder, Chronic Insomnia

Intervention / Treatment
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* Other: Music therapy with Music Care app
* Other: Sound therapy with White Noise
* Other: Treatment as usual for sleep disorders


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults over 18 years old speaking French, with sleep complaints at least 3 times a week for more than 3 months, or with a sleep medications at least 3 times a week for more than 3 months, and an ISI score (Insomnia Severity Index) greater than 14 Exclusion Criteria: Age < 18 years old. Patients with severe cognitive disorders or comprehension disorders deemed incompatible with the study protocol by the physician. Patients with severe hearing loss, not using hearing aids. Patients who do not own a music distribution device (smartphone, tablet, laptop, hifi system...). Patients without internet access.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment as usual<br>Usual treatment of sleep disorders consist of adequate sleep hygiene entails the behaviors, practices, rituals, and habits. | Other: Treatment as usual for sleep disorders<br>* No intervention<br>|
| Experimental: Music Intervention<br>Using the app Music Care | Other: Music therapy with Music Care app<br>* Listening to music with Music Care app, every day, for 20 minutes, sitting up or lying down, at bedtime, with a headset or earbuds.<br>|
| Placebo Comparator: White Noise<br>Using an app producing white noise (like rain, storm, fan, wind...) | Other: Sound therapy with White Noise<br>* Listening to white noise with an app, every day, for 20 minutes, sitting up or lying down, at bedtime, with a headset or earbuds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of anxiety | Evaluate the effect of musical interventions and white noise on patient anxiety at the beginning, during, and at the end of the study (in a scale between 1 and 4). | 3 months | 
| Quantity of sleeping medications used per week | Evaluate the effect of musical interventions and white noise on the quantity of sleeping medications used per week for sleeping at the beginning and end of the study. | 3 months | 
| Patient's overall state of well-being | Evaluation of the patient's overall state of well-being with one simple question: How do you find your health status now as compared to the beginning of the study? (Worse/No change/Slight change/Noticeable change). | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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music therapy, white noise, sleeping medicine, psychotropics