Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-25 @ 8:02 PM
Study NCT ID:
NCT05303935
Status:
COMPLETED
Last Update Posted:
2023-07-06
First Post:
2022-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Quetiapine on Sleep and Next Day Alertness in People With Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069348', 'term': 'Quetiapine Fumarate'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D003987', 'term': 'Dibenzothiazepines'}, {'id': 'D013841', 'term': 'Thiazepines'}, {'id': 'D013846', 'term': 'Thiepins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Double-blind, randomized, placebo-controlled, cross-over study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-04', 'studyFirstSubmitDate': '2022-02-24', 'studyFirstSubmitQcDate': '2022-03-21', 'lastUpdatePostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in OSA severity (Quetiapine night vs. placebo night)', 'timeFrame': 'Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.', 'description': 'OSA severity as measured by the AHI (apnoea hypopnea index measured as # events/h sleep) during overnight in-laboratory polysomnography.'}], 'secondaryOutcomes': [{'measure': 'Change in nadir overnight hypoxemia (Quetiapine night vs. placebo night)', 'timeFrame': 'Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.', 'description': 'Nadir overnight oxygen saturation during sleep (%) measured via pulse oximetry during overnight in-laboratory polysomnography.'}, {'measure': 'Change in mean overnight hypoxemia (Quetiapine night vs. placebo night)', 'timeFrame': 'Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.', 'description': 'Mean overnight oxygen saturation during sleep (%) measured via pulse oximetry during overnight in-laboratory polysomnography.'}, {'measure': 'Change in time below 90% blood arterial oxygen saturation (Quetiapine night vs. placebo night)', 'timeFrame': 'Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.', 'description': 'Percent time asleep spent below an arterial oxygen saturation of 90% measured via pulse oximetry during overnight in-laboratory polysomnography.'}, {'measure': 'Change in sleep efficiency (Quetiapine night vs. placebo night)', 'timeFrame': 'Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.', 'description': 'Percent time spent asleep divided by the recording time from lights out to lights on during overnight in-laboratory polysomnography.'}, {'measure': 'Change in arousal index (Quetiapine night vs. placebo night)', 'timeFrame': 'Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.', 'description': 'Number of cortical arousals per hour of sleep during overnight in-laboratory polysomnography.'}, {'measure': 'Change in sleep architecture (Quetiapine night vs. placebo night)', 'timeFrame': 'Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.', 'description': 'Proportion of sleep stages (% total sleep time) during overnight in-laboratory polysomnography.'}, {'measure': 'Change in respiratory control (Quetiapine night vs. placebo night)', 'timeFrame': 'Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.', 'description': 'Loop gain and the ventilatory response to arousal (% eupnea) during overnight in-laboratory polysomnography.'}, {'measure': 'Change in the respiratory arousal threshold (Quetiapine night vs. placebo night)', 'timeFrame': 'Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.', 'description': 'Threshold to arousal (% eupnea) during overnight in-laboratory polysomnography.'}, {'measure': 'Change in airway collapsibility (Quetiapine night vs. placebo night)', 'timeFrame': 'Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.', 'description': 'Vpassive (% eupnea) during overnight in-laboratory polysomnography.'}, {'measure': 'Change in pharyngeal muscle response (Quetiapine night vs. placebo night)', 'timeFrame': 'Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.', 'description': 'Vcompensation (% eupnea) during overnight in-laboratory polysomnography.'}, {'measure': 'Baseline OSA endotypes (outcomes 8-11) and whether they are associated with changes in OSA severity (Quetiapine night vs. placebo night)', 'timeFrame': 'Baseline sleep study', 'description': 'Exploratory analysis to determine if baseline OSA endotypes (outcomes 8-11) are associated with changes in OSA severity (Quetiapine night vs. placebo night)'}, {'measure': 'Change in perceived sleepiness (Quetiapine night vs. placebo night)', 'timeFrame': 'Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.', 'description': 'Next day perceived sleepiness assessed via the Karolinska Sleepiness Scale (10 point scale where 1=extremely alert and 10=extremely sleepy)'}, {'measure': 'Change in driving simulator performance (Quetiapine night vs. placebo night)', 'timeFrame': 'Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.', 'description': 'Next day alertness as measured via the AusEd driving simulator performance task'}, {'measure': 'Change in psycho-motor vigilance (Quetiapine night vs. placebo night)', 'timeFrame': 'Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.', 'description': 'Next day alertness as measured via the pschomotor vigilance test (PVT)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep apnea, obstructive', 'quetiapine', 'randomised', 'double-blind', 'placebo', 'respiratory arousal threshold'], 'conditions': ['Sleep Apnea, Obstructive']}, 'referencesModule': {'references': [{'pmid': '31556541', 'type': 'BACKGROUND', 'citation': 'Debernard KAB, Frost J, Roland PH. Quetiapine is not a sleeping pill. Tidsskr Nor Laegeforen. 2019 Sep 16;139(13). doi: 10.4045/tidsskr.19.0205. Print 2019 Sep 24. English, Norwegian.'}, {'pmid': '30359361', 'type': 'BACKGROUND', 'citation': 'McKean A, Monasterio E, Elliott T. How common is off-label prescription of quetiapine? N Z Med J. 2018 Oct 26;131(1484):77-78. No abstract available.'}, {'pmid': '25485247', 'type': 'BACKGROUND', 'citation': 'Pringsheim T, Gardner DM. Dispensed prescriptions for quetiapine and other second-generation antipsychotics in Canada from 2005 to 2012: a descriptive study. CMAJ Open. 2014 Oct 1;2(4):E225-32. doi: 10.9778/cmajo.20140009. eCollection 2014 Oct.'}, {'pmid': '15029469', 'type': 'BACKGROUND', 'citation': 'Cohrs S, Rodenbeck A, Guan Z, Pohlmann K, Jordan W, Meier A, Ruther E. Sleep-promoting properties of quetiapine in healthy subjects. Psychopharmacology (Berl). 2004 Jul;174(3):421-9. doi: 10.1007/s00213-003-1759-5. Epub 2004 Mar 17.'}, {'pmid': '28093029', 'type': 'BACKGROUND', 'citation': 'Karsten J, Hagenauw LA, Kamphuis J, Lancel M. Low doses of mirtazapine or quetiapine for transient insomnia: A randomised, double-blind, cross-over, placebo-controlled trial. J Psychopharmacol. 2017 Mar;31(3):327-337. doi: 10.1177/0269881116681399. Epub 2017 Jan 16.'}, {'pmid': '34214960', 'type': 'BACKGROUND', 'citation': 'Meira E Cruz M, Kryger MH, Morin CM, Palombini L, Salles C, Gozal D. Comorbid Insomnia and Sleep Apnea: mechanisms and implications of an underrecognized and misinterpreted sleep disorder. Sleep Med. 2021 Aug;84:283-288. doi: 10.1016/j.sleep.2021.05.043. Epub 2021 Jun 8.'}, {'pmid': '34229295', 'type': 'BACKGROUND', 'citation': 'Sweetman A, Lack L, McEvoy RD, Smith S, Eckert DJ, Osman A, Carberry JC, Wallace D, Nguyen PD, Catcheside P. Bi-directional relationships between co-morbid insomnia and sleep apnea (COMISA). Sleep Med Rev. 2021 Dec;60:101519. doi: 10.1016/j.smrv.2021.101519. Epub 2021 Jun 23.'}, {'pmid': '31300334', 'type': 'BACKGROUND', 'citation': 'Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pepin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9.'}, {'pmid': '28110857', 'type': 'BACKGROUND', 'citation': 'Eckert DJ. Phenotypic approaches to obstructive sleep apnoea - New pathways for targeted therapy. Sleep Med Rev. 2018 Feb;37:45-59. doi: 10.1016/j.smrv.2016.12.003. Epub 2016 Dec 18.'}, {'pmid': '23721582', 'type': 'BACKGROUND', 'citation': 'Eckert DJ, White DP, Jordan AS, Malhotra A, Wellman A. Defining phenotypic causes of obstructive sleep apnea. Identification of novel therapeutic targets. Am J Respir Crit Care Med. 2013 Oct 15;188(8):996-1004. doi: 10.1164/rccm.201303-0448OC.'}, {'pmid': '33965721', 'type': 'BACKGROUND', 'citation': 'Carter SG, Eckert DJ. Effects of hypnotics on obstructive sleep apnea endotypes and severity: Novel insights into pathophysiology and treatment. Sleep Med Rev. 2021 Aug;58:101492. doi: 10.1016/j.smrv.2021.101492. Epub 2021 Apr 22.'}, {'pmid': '21269278', 'type': 'BACKGROUND', 'citation': 'Eckert DJ, Owens RL, Kehlmann GB, Wellman A, Rahangdale S, Yim-Yeh S, White DP, Malhotra A. Eszopiclone increases the respiratory arousal threshold and lowers the apnoea/hypopnoea index in obstructive sleep apnoea patients with a low arousal threshold. Clin Sci (Lond). 2011 Jun;120(12):505-14. doi: 10.1042/CS20100588.'}, {'pmid': '28707161', 'type': 'BACKGROUND', 'citation': 'Khazaie H, Sharafkhaneh A, Khazaie S, Ghadami MR. A weight-independent association between atypical antipsychotic medications and obstructive sleep apnea. Sleep Breath. 2018 Mar;22(1):109-114. doi: 10.1007/s11325-017-1537-y. Epub 2017 Jul 13.'}, {'pmid': '10450601', 'type': 'BACKGROUND', 'citation': 'Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. The Report of an American Academy of Sleep Medicine Task Force. Sleep. 1999 Aug 1;22(5):667-89. No abstract available.'}], 'seeAlsoLinks': [{'url': 'http://www.medicines.org.uk/emc/product/5495/smpc', 'label': 'Compendium EM. SEROQUEL 25 mg film-coated tablets. 2021 \\[cited 2021 22/10/2021\\].'}, {'url': 'https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2020-PI-02417-1&d=20211103172310101', 'label': 'AstraZeneca. Australian Product Information Seroquel. 2020.'}]}, 'descriptionModule': {'briefSummary': 'Quetiapine is medication used to treat schizophrenia and bipolar disorder. Increasingly, low doses of quetiapine are prescribed "off-label" for insomnia. Quetiapine increases sleep duration with fewer interruptions, and people report feeling more rested. This accounts for why it is popular to prescribe for insomnia. Insomnia and obstructive sleep apnea (OSA) share many symptoms and differential diagnosis can be difficult. While quetiapine may improve sleep and breathing in certain people (i.e in light sleepers) an initial study indicated that quetiapine caused breathing disturbances in healthy individuals. Effects in OSA are unknown. In this placebo-controlled double blind study, participants with mild-moderate OSA will spend 2 nights in the sleep lab, one with quetiapine at a dose commonly prescribed for insomnia and one with placebo. The investigators will assess participants sleep by standard clinical sleep study, and morning alertness using questionnaires, reaction tests, and a driving simulator test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages: 18+ (Adult, Older Adult)\n* Gender: All\n* Moderate or more "difficulty staying asleep" score on the Insomnia Severity Index questionnaire\n* Obstructive Sleep Apnoea (OSA), Apnoea Hypopnea Index ≥ 5 events/hour\n* BMI between 18.5 and 40 kg/m2\n\nExclusion Criteria:\n\n* Concomitant medications that interact or are contraindicated with quetiapine\n* Concomitant medications known to influence breathing, sleep, arousal, or muscle physiology\n* Current pregnancy or breast-feeding\n* Current or recent other medical conditions likely to affect results or safety'}, 'identificationModule': {'nctId': 'NCT05303935', 'acronym': 'QOSA', 'briefTitle': 'Effects of Quetiapine on Sleep and Next Day Alertness in People With Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Flinders University'}, 'officialTitle': 'Effects of Quetiapine on Sleep and Next Day Alertness in People With Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': '4965'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quetiapine', 'description': 'Quetiapine 50mg in the form of one capsule, taken before bedtime. Dosage is taken on one instance for one night only.', 'interventionNames': ['Drug: Quetiapine 50 MG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo sugar pill in the form of one capsule, taken before bedtime. Dosage is taken on one instance for one night only.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Quetiapine 50 MG', 'type': 'DRUG', 'otherNames': ['Seroquel'], 'description': 'A single dose of 50mg of quetiapine taken at bedtime for one night.', 'armGroupLabels': ['Quetiapine']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sugar pill'], 'description': 'A placebo sugar pill that looks like the quetiapine tablet taken at bedtime for one night.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5042', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Adelaide Institute for Sleep Health', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}], 'overallOfficials': [{'name': 'Danny Eckert, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Flinders University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'At conclusion of study and related publications.', 'ipdSharing': 'YES', 'description': 'Participants will be informed in plain language through the consent form that their deidentified data may be made available to other researchers. Deidentified participant data will only be shared with other researchers upon request to the chief investigator after study publication and subject to ethical approval.', 'accessCriteria': 'IPD may be shared for research purposes on application to the chief investigator and subject to applicable ethical review.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Flinders University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Adelaide Institute for Sleep Health', 'investigatorFullName': 'Professor Danny Eckert', 'investigatorAffiliation': 'Flinders University'}}}}