Chronic Insomnia, Sleep Disorder
Conditions
Keywords
music therapy, white noise, sleeping medicine, psychotropics
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.
Interventions
OTHERMusic 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.
OTHERSound 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.
OTHERTreatment as usual for sleep disorders
No intervention
Sponsors
Versailles Saint-Quentin-en-Yvelines University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score on Pittsburgh Sleep Quality Index (PSQI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Severity of anxiety | 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). |
| Quantity of sleeping medications used per week | 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. |
| Patient's overall state of well-being | 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). |
Countries
France
Contacts
Primary ContactElsa Musso
Backup ContactAgnès Kirrmann
Outcome results
None listed