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Effectiveness of Music Therapy on Sleep Disorders

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ClinicalTrials.gov Identifier: NCT04578860
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
MUSSO, Versailles Saint-Quentin-en-Yvelines University

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.

Condition or disease Intervention/treatment Phase
Sleep Disorder Chronic Insomnia Other: Music therapy with Music Care app Other: Sound therapy with White Noise Other: Treatment as usual for sleep disorders Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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.
Actual Study Start Date : March 2, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04578860


Contacts
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Contact: Elsa Musso 0033630384689 etudesommeil20@gmail.com
Contact: Agnès Kirrmann 0033139650421 agnes.kirrmann@gmail.com

Locations
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France
Versailles-Saint Quentin en Yvelines University Recruiting
Versailles, Ile De France, France, 78000
Contact: Elsa Musso, Student    +33630384689    etudesommeil20@gmail.com   
Contact: Yhan Monney, Dr    +33139171251    yhan.monney@gmail.com   
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         
Sponsors and Collaborators
Versailles Saint-Quentin-en-Yvelines University
Investigators
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Principal Investigator: Elsa Musso Versailles Saint-Quentin-en-Yvelines University
Additional Information:
Publications of Results:

Other Publications:
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Responsible Party: MUSSO, PhD student in medicine, Versailles Saint-Quentin-en-Yvelines University
ClinicalTrials.gov Identifier: NCT04578860    
Other Study ID Numbers: 19.05.07.57052
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MUSSO, Versailles Saint-Quentin-en-Yvelines University:
music therapy
white noise
sleeping medicine
psychotropics
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Wake Disorders
Parasomnias
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations