NCT04578860

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 8, 2020

Status Verified

September 1, 2020

Enrollment Period

9 months

First QC Date

September 3, 2020

Last Update Submit

September 30, 2020

Conditions

Sleep DisorderChronic Insomnia

Keywords

music therapywhite noisesleeping medicinepsychotropics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Severity of anxiety

    3 months

  • Quantity of sleeping medications used per week

    3 months

  • Patient's overall state of well-being

    3 months

Study Arms (3)

Treatment as usual

ACTIVE COMPARATOR

Usual treatment of sleep disorders consist of adequate sleep hygiene entails the behaviors, practices, rituals, and habits.

Other: Treatment as usual for sleep disorders

Music Intervention

EXPERIMENTAL

Using the app Music Care

Other: Music therapy with Music Care app

White Noise

PLACEBO COMPARATOR

Using an app producing white noise (like rain, storm, fan, wind...)

Other: Sound therapy with White Noise

Interventions

Music therapy with Music Care appOTHER

Listening to music with Music Care app, every day, for 20 minutes, sitting up or lying down, at bedtime, with a headset or earbuds.

Music Intervention
Sound therapy with White NoiseOTHER

Listening to white noise with an app, every day, for 20 minutes, sitting up or lying down, at bedtime, with a headset or earbuds.

White Noise
Treatment as usual for sleep disordersOTHER

No intervention

Treatment as usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Versailles-Saint Quentin en Yvelines University

Versailles, Île-de-France Region, 78000, France

RECRUITING

Related Publications (23)

  • Harmat L, Takacs J, Bodizs 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.

    PMID: 18426457BACKGROUND

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

    PMID: 26270746BACKGROUND

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

    PMID: 9488928BACKGROUND

  • 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. doi: 10.1093/sleep/29.8.1009.

    PMID: 16944668RESULT

  • 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. 2006 May;47(5):833-9. doi: 10.1161/01.HYP.0000217362.34748.e0. Epub 2006 Apr 3.

    PMID: 16585410RESULT

  • 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. doi: 10.1152/japplphysiol.00660.2005.

    PMID: 16227462RESULT

  • 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. doi: 10.1046/j.1365-2869.2000.00178.x.

    PMID: 10733687RESULT

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

    PMID: 15575799RESULT

  • 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 2017 Oct 23.

    PMID: 29100201RESULT

  • 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.

    PMID: 23582682RESULT

  • Guetin S, Coudeyre E, Picot MC, Ginies P, Graber-Duvernay B, Ratsimba D, Vanbiervliet W, Blayac JP, Herisson C. [Effect of music therapy among hospitalized patients with chronic low back pain: a controlled, randomized trial]. Ann Readapt Med Phys. 2005 Jun;48(5):217-24. doi: 10.1016/j.annrmp.2005.02.003. Epub 2005 Mar 4. French.

    PMID: 15914256RESULT

  • Guetin S, Portet F, Picot MC, Pommie 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 Disord. 2009;28(1):36-46. doi: 10.1159/000229024. Epub 2009 Jul 23.

    PMID: 19628939RESULT

  • Jaber S, Bahloul H, Guetin 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. doi: 10.1016/j.annfar.2006.09.002. Epub 2006 Nov 3. French.

    PMID: 17085009RESULT

  • Guetin S, Ginies P, Siou DK, Picot MC, Pommie 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: 10.1097/AJP.0b013e31822be973.

    PMID: 22001666RESULT

  • 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):57-65. doi: 10.1016/j.encep.2007.10.009. Epub 2008 Feb 20. French.

    PMID: 19250995RESULT

  • Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.

    PMID: 11438246RESULT

  • Morin CM, Belleville G, Belanger 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. doi: 10.1093/sleep/34.5.601.

    PMID: 21532953RESULT

  • 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. doi: 10.1002/pon.860.

    PMID: 15376284RESULT

  • 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. doi: 10.1016/0165-1781(89)90047-4.

    PMID: 2748771RESULT

  • 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. doi: 10.1016/s1389-9457(01)00078-8.

    PMID: 14592264RESULT

  • 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.

    PMID: 1947597RESULT

  • 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.

    PMID: 27223689RESULT

  • Jespersen KV, Pando-Naude V, Koenig J, Jennum P, Vuust P. Listening to music for insomnia in adults. Cochrane Database Syst Rev. 2022 Aug 24;8(8):CD010459. doi: 10.1002/14651858.CD010459.pub3.

    PMID: 36000763DERIVED

Related Links

MeSH Terms

Conditions

Sleep Wake DisordersSleep Initiation and Maintenance Disorders

Interventions

Music TherapyTherapeutics

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersSleep Disorders, IntrinsicDyssomnias

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Elsa Musso

    Versailles Saint-Quentin-en-Yvelines University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elsa Musso

CONTACT

0033630384689etudesommeil20@gmail.com

Agnès Kirrmann

CONTACT

0033139650421agnes.kirrmann@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student in medicine

Study Record Dates

First Submitted

September 3, 2020

First Posted

October 8, 2020

Study Start

March 2, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

October 8, 2020

Record last verified: 2020-09

Locations

FR(1)