NCT04578860

Effectiveness of Music Therapy on Sleep Disorders

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Versailles Saint-Quentin-en-Yvelines University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Sleep Disorder
• Chronic Insomnia

Interventions

Type	Name	Description
OTHER	Music therapy with Music Care app	Listening to music with Music Care app, every day, for 20 minutes, sitting up or lying down, at bedtime, with a headset or earbuds.
OTHER	Sound therapy with White Noise	Listening to white noise with an app, every day, for 20 minutes, sitting up or lying down, at bedtime, with a headset or earbuds.
OTHER	Treatment as usual for sleep disorders	No intervention

Timeline

• Start date: 2020-03-02
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2020-10-08
• Last updated: 2020-10-08

Locations

1 site across 1 country: France