Clinical trial NCT04578860: Effectiveness of Music Therapy on Sleep Disorders
Official title: A 3-months, Controlled and Double-blind Trial of the Effectiveness of Music Therapy in the Treatment of Sleep Disorders in General Medicine.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Disorder
Chronic Insomnia
Keywords: music therapy
white noise
sleeping medicine
psychotropics
Lead sponsor: Versailles Saint-Quentin-en-Yvelines University
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Score on Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 3 months
Secondary outcomes:
measure: Severity of anxiety
timeFrame: 3 months
measure: Quantity of sleeping medications used per week
timeFrame: 3 months
measure: Patient's overall state of well-being
timeFrame: 3 months
Other outcomes:
Locations:
city: Versailles
country: France
facility: Versailles-Saint Quentin en Yvelines University
state: Ile De France
Study officials:
affiliation: Versailles Saint-Quentin-en-Yvelines University
name: Elsa Musso
role: PRINCIPAL_INVESTIGATOR
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