Effectiveness of Music Therapy on Sleep Disorders
Primary Purpose
Sleep Disorder, Chronic Insomnia
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Music therapy with Music Care app
Sound therapy with White Noise
Treatment as usual for sleep disorders
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Disorder focused on measuring music therapy, white noise, sleeping medicine, psychotropics
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.
Sites / Locations
- Versailles-Saint Quentin en Yvelines UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Placebo Comparator
Arm Label
Treatment as usual
Music Intervention
White Noise
Arm Description
Usual treatment of sleep disorders consist of adequate sleep hygiene entails the behaviors, practices, rituals, and habits.
Using the app Music Care
Using an app producing white noise (like rain, storm, fan, wind...)
Outcomes
Primary Outcome Measures
Score on Pittsburgh Sleep Quality Index (PSQI)
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
Severity of anxiety
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).
Quantity of sleeping medications used per week
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.
Patient's overall state of well-being
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).
Full Information
NCT ID
NCT04578860
First Posted
September 3, 2020
Last Updated
September 30, 2020
Sponsor
Versailles Saint-Quentin-en-Yvelines University
1. Study Identification
Unique Protocol Identification Number
NCT04578860
Brief Title
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
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Versailles Saint-Quentin-en-Yvelines University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder, Chronic Insomnia
Keywords
music therapy, white noise, sleeping medicine, psychotropics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Usual treatment of sleep disorders consist of adequate sleep hygiene entails the behaviors, practices, rituals, and habits.
Arm Title
Music Intervention
Arm Type
Experimental
Arm Description
Using the app Music Care
Arm Title
White Noise
Arm Type
Placebo Comparator
Arm Description
Using an app producing white noise (like rain, storm, fan, wind...)
Intervention Type
Other
Intervention Name(s)
Music therapy with Music Care app
Intervention Description
Listening to music with Music Care app, every day, for 20 minutes, sitting up or lying down, at bedtime, with a headset or earbuds.
Intervention Type
Other
Intervention Name(s)
Sound therapy with White Noise
Intervention Description
Listening to white noise with an app, every day, for 20 minutes, sitting up or lying down, at bedtime, with a headset or earbuds.
Intervention Type
Other
Intervention Name(s)
Treatment as usual for sleep disorders
Intervention Description
No intervention
Primary Outcome Measure Information:
Title
Score on Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Severity of anxiety
Description
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).
Time Frame
3 months
Title
Quantity of sleeping medications used per week
Description
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.
Time Frame
3 months
Title
Patient's overall state of well-being
Description
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).
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elsa Musso
Phone
0033630384689
Email
etudesommeil20@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Agnès Kirrmann
Phone
0033139650421
Email
agnes.kirrmann@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elsa Musso
Organizational Affiliation
Versailles Saint-Quentin-en-Yvelines University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Versailles-Saint Quentin en Yvelines University
City
Versailles
State/Province
Ile De France
ZIP/Postal Code
78000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elsa Musso, Student
Phone
+33630384689
Email
etudesommeil20@gmail.com
First Name & Middle Initial & Last Name & Degree
Yhan Monney, Dr
Phone
+33139171251
Email
yhan.monney@gmail.com
First Name & Middle Initial & Last Name & Degree
Elsa Musso, Student
First Name & Middle Initial & Last Name & Degree
Agnès Kirrmann, Dr
First Name & Middle Initial & Last Name & Degree
Yhan Monney, Dr
First Name & Middle Initial & Last Name & Degree
Amélie Bijon, Dr
First Name & Middle Initial & Last Name & Degree
Olivier Saint Lary, Pr
First Name & Middle Initial & Last Name & Degree
Lea Prevost, Dr
First Name & Middle Initial & Last Name & Degree
Christophe Gryson, Dr
First Name & Middle Initial & Last Name & Degree
Pierre Sarafian, Dr
First Name & Middle Initial & Last Name & Degree
Jeanne Lanoe, Dr
First Name & Middle Initial & Last Name & Degree
Michel Fauve, Dr
First Name & Middle Initial & Last Name & Degree
Marc Nuffer, Dr
First Name & Middle Initial & Last Name & Degree
Cécile Foisel, Dr
First Name & Middle Initial & Last Name & Degree
Caroline Rihm, Dr
First Name & Middle Initial & Last Name & Degree
Manon Guéhin, Dr
First Name & Middle Initial & Last Name & Degree
Devillers Louise, Dr
First Name & Middle Initial & Last Name & Degree
Josse Philippe, Dr
First Name & Middle Initial & Last Name & Degree
Michel Villiers-Moriame, Dr
First Name & Middle Initial & Last Name & Degree
Alain Jami, Pr
First Name & Middle Initial & Last Name & Degree
Annyck Landry-Chassot, Dr
First Name & Middle Initial & Last Name & Degree
Eric Cavaille-Coll, Dr
First Name & Middle Initial & Last Name & Degree
Frédéric Urbain, Pr
First Name & Middle Initial & Last Name & Degree
Juliette Berrier, Dr
First Name & Middle Initial & Last Name & Degree
Juliette Vandendriessche, Dr
12. IPD Sharing Statement
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Links:
URL
http://musicotherapie.info/le-centre/le-cim/
Description
Centre International de Musicothérapie. Historique du C.I.M
URL
https://solidarites-sante.gouv.fr/IMG/pdf/rapport-5.pdf
Description
Giordanella JP. Rapport sur le thème du sommeil. Ministère de la Santé et des Solidarités. Décembre 2006
URL
https://www.afm-musicotherapie.org/
Description
Association Française de Musicothérapie. L'A.F.M et la musicothérapie
URL
https://www.musicotherapie-federationfrancaise.com/missions/
Description
Fédération Française de Musicothérapie. Fédération Française de Musicothérapie
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Effectiveness of Music Therapy on Sleep Disorders
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