Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 4:39 PM
Study NCT ID:
NCT04578860
Status:
UNKNOWN
Last Update Posted:
2020-10-08
First Post:
2020-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Music Therapy on Sleep Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009147', 'term': 'Music Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-30', 'studyFirstSubmitDate': '2020-09-03', 'studyFirstSubmitQcDate': '2020-09-30', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score on Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '3 months', '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.'}], 'secondaryOutcomes': [{'measure': 'Severity of anxiety', 'timeFrame': '3 months', '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).'}, {'measure': 'Quantity of sleeping medications used per week', 'timeFrame': '3 months', '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.'}, {'measure': "Patient's overall state of well-being", 'timeFrame': '3 months', '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)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['music therapy', 'white noise', 'sleeping medicine', 'psychotropics'], 'conditions': ['Sleep Disorder', 'Chronic Insomnia']}, 'referencesModule': {'references': [{'pmid': '18426457', 'type': 'BACKGROUND', 'citation': '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': '26270746', 'type': 'BACKGROUND', 'citation': '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': '9488928', 'type': 'BACKGROUND', '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.'}, {'pmid': '16944668', 'type': 'RESULT', '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. doi: 10.1093/sleep/29.8.1009.'}, {'pmid': '16585410', 'type': 'RESULT', '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. 2006 May;47(5):833-9. doi: 10.1161/01.HYP.0000217362.34748.e0. Epub 2006 Apr 3.'}, {'pmid': '16227462', 'type': 'RESULT', '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. doi: 10.1152/japplphysiol.00660.2005.'}, {'pmid': '10733687', 'type': 'RESULT', '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. doi: 10.1046/j.1365-2869.2000.00178.x.'}, {'pmid': '15575799', 'type': 'RESULT', 'citation': 'Young TB. Epidemiology of daytime sleepiness: definitions, symptomatology, and prevalence. J Clin Psychiatry. 2004;65 Suppl 16:12-6.'}, {'pmid': '29100201', 'type': 'RESULT', '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 2017 Oct 23.'}, {'pmid': '23582682', 'type': 'RESULT', '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.'}, {'pmid': '15914256', 'type': 'RESULT', 'citation': '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': '19628939', 'type': 'RESULT', 'citation': "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': '17085009', 'type': 'RESULT', 'citation': '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': '22001666', 'type': 'RESULT', 'citation': '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': '19250995', 'type': 'RESULT', '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):57-65. doi: 10.1016/j.encep.2007.10.009. Epub 2008 Feb 20. French."}, {'pmid': '11438246', 'type': 'RESULT', 'citation': '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': '21532953', 'type': 'RESULT', 'citation': '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': '15376284', 'type': 'RESULT', '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. doi: 10.1002/pon.860.'}, {'pmid': '2748771', 'type': 'RESULT', '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. doi: 10.1016/0165-1781(89)90047-4.'}, {'pmid': '14592264', 'type': 'RESULT', '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. doi: 10.1016/s1389-9457(01)00078-8.'}, {'pmid': '1947597', 'type': 'RESULT', '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.'}, {'pmid': '27223689', 'type': 'RESULT', '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.'}, {'pmid': '36000763', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://musicotherapie.info/le-centre/le-cim/', 'label': 'Centre International de Musicothérapie. Historique du C.I.M'}, {'url': 'https://solidarites-sante.gouv.fr/IMG/pdf/rapport-5.pdf', 'label': 'Giordanella JP. Rapport sur le thème du sommeil. Ministère de la Santé et des Solidarités. Décembre 2006'}, {'url': 'https://www.afm-musicotherapie.org/', 'label': "Association Française de Musicothérapie. L'A.F.M et la musicothérapie"}, {'url': 'https://www.musicotherapie-federationfrancaise.com/missions/', 'label': 'Fédération Française de Musicothérapie. Fédération Française de Musicothérapie'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether listening to music before falling asleep can improve sleep quality in patients with sleep disorders.', 'detailedDescription': "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.\n\nTreatment 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.\n\nIt 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%.\n\nThe 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.\n\nMusical 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults over 18 years old\n* speaking French,\n* with sleep complaints at least 3 times a week for more than 3 months,\n* or with a sleep medications at least 3 times a week for more than 3 months,\n* and an ISI score (Insomnia Severity Index) greater than 14\n\nExclusion Criteria:\n\n* Age \\< 18 years old.\n* Patients with severe cognitive disorders or comprehension disorders deemed incompatible with the study protocol by the physician.\n* Patients with severe hearing loss, not using hearing aids.\n* Patients who do not own a music distribution device (smartphone, tablet, laptop, hifi system...).\n* Patients without internet access.'}, 'identificationModule': {'nctId': 'NCT04578860', 'briefTitle': 'Effectiveness of Music Therapy on Sleep Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Versailles Saint-Quentin-en-Yvelines University'}, 'officialTitle': 'A 3-months, Controlled and Double-blind Trial of the Effectiveness of Music Therapy in the Treatment of Sleep Disorders in General Medicine.', 'orgStudyIdInfo': {'id': '19.05.07.57052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as usual', 'description': 'Usual treatment of sleep disorders consist of adequate sleep hygiene entails the behaviors, practices, rituals, and habits.', 'interventionNames': ['Other: Treatment as usual for sleep disorders']}, {'type': 'EXPERIMENTAL', 'label': 'Music Intervention', 'description': 'Using the app Music Care', 'interventionNames': ['Other: Music therapy with Music Care app']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'White Noise', 'description': 'Using an app producing white noise (like rain, storm, fan, wind...)', 'interventionNames': ['Other: Sound therapy with White Noise']}], 'interventions': [{'name': 'Music therapy with Music Care app', 'type': 'OTHER', '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.', 'armGroupLabels': ['Music Intervention']}, {'name': 'Sound therapy with White Noise', 'type': 'OTHER', '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.', 'armGroupLabels': ['White Noise']}, {'name': 'Treatment as usual for sleep disorders', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Treatment as usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78000', 'city': 'Versailles', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Elsa Musso, Student', 'role': 'CONTACT', 'email': 'etudesommeil20@gmail.com', 'phone': '+33630384689'}, {'name': 'Yhan Monney, Dr', 'role': 'CONTACT', 'email': 'yhan.monney@gmail.com', 'phone': '+33139171251'}, {'name': 'Elsa Musso, Student', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Agnès Kirrmann, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yhan Monney, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Amélie Bijon, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Olivier Saint Lary, Pr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lea Prevost, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christophe Gryson, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pierre Sarafian, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jeanne Lanoe, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michel Fauve, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marc Nuffer, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cécile Foisel, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Caroline Rihm, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Manon Guéhin, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Devillers Louise, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Josse Philippe, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michel Villiers-Moriame, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alain Jami, Pr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Annyck Landry-Chassot, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eric Cavaille-Coll, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Frédéric Urbain, Pr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Juliette Berrier, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Juliette Vandendriessche, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Versailles-Saint Quentin en Yvelines University', 'geoPoint': {'lat': 48.80359, 'lon': 2.13424}}], 'centralContacts': [{'name': 'Elsa Musso', 'role': 'CONTACT', 'email': 'etudesommeil20@gmail.com', 'phone': '0033630384689'}, {'name': 'Agnès Kirrmann', 'role': 'CONTACT', 'email': 'agnes.kirrmann@gmail.com', 'phone': '0033139650421'}], 'overallOfficials': [{'name': 'Elsa Musso', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Versailles Saint-Quentin-en-Yvelines University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Versailles Saint-Quentin-en-Yvelines University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student in medicine', 'investigatorFullName': 'MUSSO', 'investigatorAffiliation': 'Versailles Saint-Quentin-en-Yvelines University'}}}}