Effectiveness of Music Therapy on Sleep Disorders

Versailles Saint-Quentin-en-Yvelines University

Status: Unknown

Conditions: Chronic Insomnia; Sleep Disorder

Treatments: Other: Sound therapy with White Noise; Other: Music therapy with Music Care app; Other: Treatment as usual for sleep disorders

Study type: Interventional

Funder types: Other

Identifiers

NCT04578860

19.05.07.57052

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups, including a placebo group

Treatment as usual

Active Comparator group

Description:

Usual treatment of sleep disorders consist of adequate sleep hygiene entails the behaviors, practices, rituals, and habits.

Treatment:

Other: Treatment as usual for sleep disorders

Music Intervention

Experimental group

Description:

Using the app Music Care

Treatment:

Other: Music therapy with Music Care app

White Noise

Placebo Comparator group

Description:

Using an app producing white noise (like rain, storm, fan, wind...)

Treatment:

Other: Sound therapy with White Noise