Effectiveness of Music Therapy on Sleep Disorders

Sleep Disorder Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04578860
• Other study ID #: 19.05.07.57052
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2020
• Est. completion date: December 2020

Study information

• Verified date: September 2020
• Source: Versailles Saint-Quentin-en-Yvelines University
• Contact: Elsa Musso
• Phone: 0033630384689
• Email: etudesommeil20[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Insomnia
• Parasomnias
• Sleep Disorder
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders

Intervention

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.
• 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.
• Treatment as usual for sleep disorders
No intervention

Locations

Country	Name	City	State
France	Versailles-Saint Quentin en Yvelines University	Versailles	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Versailles Saint-Quentin-en-Yvelines University

Country where clinical trial is conducted

France, 

References & Publications (22)

Bastien CH, Vallières A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. — View Citation

Blais FC, Gendron L, Mimeault V, Morin CM. [Evaluation of insomnia: validity of 3 questionnaires]. Encephale. 1997 Nov-Dec;23(6):447-53. French. — View Citation

Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. — View Citation

Buysse DJ, Reynolds CF 3rd, Monk TH, Hoch CC, Yeager AL, Kupfer DJ. Quantification of subjective sleep quality in healthy elderly men and women using the Pittsburgh Sleep Quality Index (PSQI). Sleep. 1991 Aug;14(4):331-8. Erratum in: Sleep 1992 Feb;15(1): — View Citation

Edinger JD, Wohlgemuth WK. Psychometric comparisons of the standard and abbreviated DBAS-10 versions of the dysfunctional beliefs and attitudes about sleep questionnaire. Sleep Med. 2001 Nov;2(6):493-500. — View Citation

Feng F, Zhang Y, Hou J, Cai J, Jiang Q, Li X, Zhao Q, Li BA. Can music improve sleep quality in adults with primary insomnia? A systematic review and network meta-analysis. Int J Nurs Stud. 2018 Jan;77:189-196. doi: 10.1016/j.ijnurstu.2017.10.011. Epub 20 — View Citation

Gangwisch JE, Heymsfield SB, Boden-Albala B, Buijs RM, Kreier F, Pickering TG, Rundle AG, Zammit GK, Malaspina D. Short sleep duration as a risk factor for hypertension: analyses of the first National Health and Nutrition Examination Survey. Hypertension. — View Citation

Gottlieb DJ, Redline S, Nieto FJ, Baldwin CM, Newman AB, Resnick HE, Punjabi NM. Association of usual sleep duration with hypertension: the Sleep Heart Health Study. Sleep. 2006 Aug;29(8):1009-14. — View Citation

Guétin S, Coudeyre E, Picot MC, Ginies P, Graber-Duvernay B, Ratsimba D, Vanbiervliet W, Blayac JP, Hérisson C. [Effect of music therapy among hospitalized patients with chronic low back pain: a controlled, randomized trial]. Ann Readapt Med Phys. 2005 Ju — View Citation

Guétin S, Giniès P, Siou DK, Picot MC, Pommié C, Guldner E, Gosp AM, Ostyn K, Coudeyre E, Touchon J. The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial. Clin J Pain. 2012 May;28(4):329-37. doi — View Citation

Guetin S, Portet F, Picot MC, Defez C, Pose C, Blayac JP, Touchon J. [Impact of music therapy on anxiety and depression for patients with Alzheimer's disease and on the burden felt by the main caregiver (feasibility study)]. Encephale. 2009 Feb;35(1):57-6 — View Citation

Guétin S, Portet F, Picot MC, Pommié C, Messaoudi M, Djabelkir L, Olsen AL, Cano MM, Lecourt E, Touchon J. Effect of music therapy on anxiety and depression in patients with Alzheimer's type dementia: randomised, controlled study. Dement Geriatr Cogn Diso — View Citation

Harmat L, Takács J, Bódizs R. Music improves sleep quality in students. J Adv Nurs. 2008 May;62(3):327-35. doi: 10.1111/j.1365-2648.2008.04602.x. — View Citation

Jaber S, Bahloul H, Guétin S, Chanques G, Sebbane M, Eledjam JJ. [Effects of music therapy in intensive care unit without sedation in weaning patients versus non-ventilated patients]. Ann Fr Anesth Reanim. 2007 Jan;26(1):30-8. Epub 2006 Nov 3. French. — View Citation

Jespersen KV, Koenig J, Jennum P, Vuust P. Music for insomnia in adults. Cochrane Database Syst Rev. 2015 Aug 13;(8):CD010459. doi: 10.1002/14651858.CD010459.pub2. Review. — View Citation

Leger D, Guilleminault C, Dreyfus JP, Delahaye C, Paillard M. Prevalence of insomnia in a survey of 12,778 adults in France. J Sleep Res. 2000 Mar;9(1):35-42. — View Citation

Morin CM, Belleville G, Bélanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. — View Citation

Savard MH, Savard J, Simard S, Ivers H. Empirical validation of the Insomnia Severity Index in cancer patients. Psychooncology. 2005 Jun;14(6):429-41. — View Citation

Spiegel K, Knutson K, Leproult R, Tasali E, Van Cauter E. Sleep loss: a novel risk factor for insulin resistance and Type 2 diabetes. J Appl Physiol (1985). 2005 Nov;99(5):2008-19. Review. — View Citation

Wang CF, Sun YL, Zang HX. Music therapy improves sleep quality in acute and chronic sleep disorders: a meta-analysis of 10 randomized studies. Int J Nurs Stud. 2014 Jan;51(1):51-62. doi: 10.1016/j.ijnurstu.2013.03.008. Epub 2013 Apr 9. Review. — View Citation

Wang Q, Chair SY, Wong EM, Li X. The Effects of Music Intervention on Sleep Quality in Community-Dwelling Elderly. J Altern Complement Med. 2016 Jul;22(7):576-84. doi: 10.1089/acm.2015.0304. Epub 2016 May 25. — View Citation

Young TB. Epidemiology of daytime sleepiness: definitions, symptomatology, and prevalence. J Clin Psychiatry. 2004;65 Suppl 16:12-6. Review. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	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).	3 months
Secondary	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.	3 months
Secondary	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).	3 months

External Links

•   Association Française de Musicothérapie. L'A.F.M et la musicothérapie
•   Centre International de Musicothérapie. Historique du C.I.M
•   Fédération Française de Musicothérapie. Fédération Française de Musicothérapie
•   Giordanella JP. Rapport sur le thème du sommeil. Ministère de la Santé et des Solidarités. Décembre 2006