An interventional study of Music therapy with Music Care app and Sound therapy with White Noise in Sleep Disorder and Chronic Insomnia, sponsored by Versailles Saint-Quentin-en-Yvelines University. Status unknown at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by Versailles Saint-Quentin-en-Yvelines University · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether listening to music before falling asleep can improve sleep quality in patients with sleep disorders.
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.
788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.
This study's planned enrollment of 120 is above the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →This is the only study on the registry with Versailles Saint-Quentin-en-Yvelines University as lead sponsor.
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Exclusion Criteria:
Usual treatment of sleep disorders consist of adequate sleep hygiene entails the behaviors, practices, rituals, and habits.
Other: Treatment as usual for sleep disorders
Using the app Music Care
Other: Music therapy with Music Care app
Using an app producing white noise (like rain, storm, fan, wind...)
Other: Sound therapy with White Noise
Listening to music with Music Care app, every day, for 20 minutes, sitting up or lying down, at bedtime, with a headset or earbuds.
Listening to white noise with an app, every day, for 20 minutes, sitting up or lying down, at bedtime, with a headset or earbuds.
No intervention
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.
Time frame: 3 months
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).
Time frame: 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.
Time frame: 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).
Time frame: 3 months
This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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