Effectiveness of Music Therapy on Sleep Disorders

September 30, 2020 updated by: MUSSO, Versailles Saint-Quentin-en-Yvelines University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile De France
      • Versailles, Ile De France, France, 78000
        • Recruiting
        • Versailles-Saint Quentin en Yvelines University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elsa Musso, Student
        • Sub-Investigator:
          • Agnès Kirrmann, Dr
        • Sub-Investigator:
          • Yhan Monney, Dr
        • Sub-Investigator:
          • Amélie Bijon, Dr
        • Sub-Investigator:
          • Olivier Saint Lary, Pr
        • Sub-Investigator:
          • Lea Prevost, Dr
        • Sub-Investigator:
          • Christophe Gryson, Dr
        • Sub-Investigator:
          • Pierre Sarafian, Dr
        • Sub-Investigator:
          • Jeanne Lanoe, Dr
        • Sub-Investigator:
          • Michel Fauve, Dr
        • Sub-Investigator:
          • Marc Nuffer, Dr
        • Sub-Investigator:
          • Cécile Foisel, Dr
        • Sub-Investigator:
          • Caroline Rihm, Dr
        • Sub-Investigator:
          • Manon Guéhin, Dr
        • Sub-Investigator:
          • Devillers Louise, Dr
        • Sub-Investigator:
          • Josse Philippe, Dr
        • Sub-Investigator:
          • Michel Villiers-Moriame, Dr
        • Sub-Investigator:
          • Alain Jami, Pr
        • Sub-Investigator:
          • Annyck Landry-Chassot, Dr
        • Sub-Investigator:
          • Eric Cavaille-Coll, Dr
        • Sub-Investigator:
          • Frédéric Urbain, Pr
        • Sub-Investigator:
          • Juliette Berrier, Dr
        • Sub-Investigator:
          • Juliette Vandendriessche, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment as usual
Usual treatment of sleep disorders consist of adequate sleep hygiene entails the behaviors, practices, rituals, and habits.
Other: Treatment as usual for sleep disorders
No intervention
Experimental: Music Intervention
Using the app Music Care
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.
Placebo Comparator: White Noise
Using an app producing white noise (like rain, storm, fan, wind...)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score on Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Versailles Saint-Quentin-en-Yvelines University

Investigators

  • Principal Investigator: Elsa Musso, Versailles Saint-Quentin-en-Yvelines University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

September 3, 2020

First Submitted That Met QC Criteria

September 30, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

September 30, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19.05.07.57052

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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