- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05303935
Effects of Quetiapine on Sleep and Next Day Alertness in People With Obstructive Sleep Apnea (QOSA)
July 4, 2023 updated by: Professor Danny Eckert, Flinders University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Carolin Tran
- Phone Number: +61 087421 9873
- Email: carolin.tran@flinders.edu.au
Study Contact Backup
- Name: Kelly Loffler
- Phone Number: +61 08 7221 8314
- Email: kelly.loffler@flinders.edu.au
Study Locations
-
-
South Australia
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Adelaide, South Australia, Australia, 5042
- Adelaide Institute for Sleep Health
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Ages: 18+ (Adult, Older Adult)
- Gender: All
- Moderate or more "difficulty staying asleep" score on the Insomnia Severity Index questionnaire
- Obstructive Sleep Apnoea (OSA), Apnoea Hypopnea Index ≥ 5 events/hour
- BMI between 18.5 and 40 kg/m2
Exclusion Criteria:
- Concomitant medications that interact or are contraindicated with quetiapine
- Concomitant medications known to influence breathing, sleep, arousal, or muscle physiology
- Current pregnancy or breast-feeding
- Current or recent other medical conditions likely to affect results or safety
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Quetiapine
Quetiapine 50mg in the form of one capsule, taken before bedtime.
Dosage is taken on one instance for one night only.
|
A single dose of 50mg of quetiapine taken at bedtime for one night.
Other Names:
|
Placebo Comparator: Placebo
Placebo sugar pill in the form of one capsule, taken before bedtime.
Dosage is taken on one instance for one night only.
|
A placebo sugar pill that looks like the quetiapine tablet taken at bedtime for one night.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in OSA severity (Quetiapine night vs. placebo night)
Time Frame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
|
OSA severity as measured by the AHI (apnoea hypopnea index measured as # events/h sleep) during overnight in-laboratory polysomnography.
|
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in nadir overnight hypoxemia (Quetiapine night vs. placebo night)
Time Frame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
|
Nadir overnight oxygen saturation during sleep (%) measured via pulse oximetry during overnight in-laboratory polysomnography.
|
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
|
Change in mean overnight hypoxemia (Quetiapine night vs. placebo night)
Time Frame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
|
Mean overnight oxygen saturation during sleep (%) measured via pulse oximetry during overnight in-laboratory polysomnography.
|
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
|
Change in time below 90% blood arterial oxygen saturation (Quetiapine night vs. placebo night)
Time Frame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
|
Percent time asleep spent below an arterial oxygen saturation of 90% measured via pulse oximetry during overnight in-laboratory polysomnography.
|
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
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Change in sleep efficiency (Quetiapine night vs. placebo night)
Time Frame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
|
Percent time spent asleep divided by the recording time from lights out to lights on during overnight in-laboratory polysomnography.
|
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
|
Change in arousal index (Quetiapine night vs. placebo night)
Time Frame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
|
Number of cortical arousals per hour of sleep during overnight in-laboratory polysomnography.
|
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
|
Change in sleep architecture (Quetiapine night vs. placebo night)
Time Frame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
|
Proportion of sleep stages (% total sleep time) during overnight in-laboratory polysomnography.
|
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
|
Change in respiratory control (Quetiapine night vs. placebo night)
Time Frame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
|
Loop gain and the ventilatory response to arousal (% eupnea) during overnight in-laboratory polysomnography.
|
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
|
Change in the respiratory arousal threshold (Quetiapine night vs. placebo night)
Time Frame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
|
Threshold to arousal (% eupnea) during overnight in-laboratory polysomnography.
|
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
|
Change in airway collapsibility (Quetiapine night vs. placebo night)
Time Frame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
|
Vpassive (% eupnea) during overnight in-laboratory polysomnography.
|
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
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Change in pharyngeal muscle response (Quetiapine night vs. placebo night)
Time Frame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
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Vcompensation (% eupnea) during overnight in-laboratory polysomnography.
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Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
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Baseline OSA endotypes (outcomes 8-11) and whether they are associated with changes in OSA severity (Quetiapine night vs. placebo night)
Time Frame: Baseline sleep study
|
Exploratory analysis to determine if baseline OSA endotypes (outcomes 8-11) are associated with changes in OSA severity (Quetiapine night vs. placebo night)
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Baseline sleep study
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Change in perceived sleepiness (Quetiapine night vs. placebo night)
Time Frame: Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
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Next day perceived sleepiness assessed via the Karolinska Sleepiness Scale (10 point scale where 1=extremely alert and 10=extremely sleepy)
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Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
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Change in driving simulator performance (Quetiapine night vs. placebo night)
Time Frame: Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
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Next day alertness as measured via the AusEd driving simulator performance task
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Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
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Change in psycho-motor vigilance (Quetiapine night vs. placebo night)
Time Frame: Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
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Next day alertness as measured via the pschomotor vigilance test (PVT)
|
Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Danny Eckert, PhD, Flinders University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 25, 2022
Primary Completion (Actual)
April 4, 2023
Study Completion (Actual)
April 4, 2023
Study Registration Dates
First Submitted
February 24, 2022
First Submitted That Met QC Criteria
March 21, 2022
First Posted (Actual)
March 31, 2022
Study Record Updates
Last Update Posted (Actual)
July 6, 2023
Last Update Submitted That Met QC Criteria
July 4, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Signs and Symptoms, Respiratory
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Apnea
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- Quetiapine Fumarate
Other Study ID Numbers
- 4965
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan 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.
IPD Sharing Time Frame
At conclusion of study and related publications.
IPD Sharing Access Criteria
IPD may be shared for research purposes on application to the chief investigator and subject to applicable ethical review.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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