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Sleep Apnea, ObstructivePhase 2QOSANCT05303935

Effects of Quetiapine on Sleep and Next Day Alertness in People With Obstructive Sleep Apnea

A Phase 2 study testing Quetiapine 50 MG in people with Sleep Apnea, Obstructive, run by Flinders University at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sleep Apnea, Obstructive
What is being tested?
Quetiapine 50 MG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
1 siteAustralia
Study dates
25 May 2022to 4 Apr 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Adelaide Institute for Sleep Health

    Adelaide, South Australia, 5042

Other trials in Australia

About this study

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.

Being tested
Quetiapine 50 MG, Placebo
Keywords
Sleep apnea, obstructive, quetiapine, randomised, double-blind, placebo, respiratory arousal threshold
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quetiapine 50 MGDrug

    Also called Seroquel

    A single dose of 50mg of quetiapine taken at bedtime for one night.

  • PlaceboDrug

    Also called Sugar pill

    A placebo sugar pill that looks like the quetiapine tablet taken at bedtime for one night.

Study groups in NCT05303935
Study groupRoleWhat they receive
QuetiapineExperimentalQuetiapine 50mg in the form of one capsule, taken before bedtime. Dosage is taken on one instance for one night only.
Receives: Drug: Quetiapine 50 MG
PlaceboPlacebo comparatorPlacebo sugar pill in the form of one capsule, taken before bedtime. Dosage is taken on one instance for one night only.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in OSA severity (Quetiapine night vs. placebo night)

    OSA severity as measured by the AHI (apnoea hypopnea index measured as # events/h sleep) during overnight in-laboratory polysomnography.

    Measured: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.

Secondary outcomes (14)

  1. Change in nadir overnight hypoxemia (Quetiapine night vs. placebo night)

    Nadir overnight oxygen saturation during sleep (%) measured via pulse oximetry during overnight in-laboratory polysomnography.

    Measured: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.

  2. Change in mean overnight hypoxemia (Quetiapine night vs. placebo night)

    Mean overnight oxygen saturation during sleep (%) measured via pulse oximetry during overnight in-laboratory polysomnography.

    Measured: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.

  3. Change in time below 90% blood arterial oxygen saturation (Quetiapine night vs. placebo night)

    Percent time asleep spent below an arterial oxygen saturation of 90% measured via pulse oximetry during overnight in-laboratory polysomnography.

    Measured: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.

  4. Change in sleep efficiency (Quetiapine night vs. placebo night)

    Percent time spent asleep divided by the recording time from lights out to lights on during overnight in-laboratory polysomnography.

    Measured: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.

  5. Change in arousal index (Quetiapine night vs. placebo night)

    Number of cortical arousals per hour of sleep during overnight in-laboratory polysomnography.

    Measured: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.

  6. Change in sleep architecture (Quetiapine night vs. placebo night)

    Proportion of sleep stages (% total sleep time) during overnight in-laboratory polysomnography.

    Measured: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.

  7. Change in respiratory control (Quetiapine night vs. placebo night)

    Loop gain and the ventilatory response to arousal (% eupnea) during overnight in-laboratory polysomnography.

    Measured: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.

  8. Change in the respiratory arousal threshold (Quetiapine night vs. placebo night)

    Threshold to arousal (% eupnea) during overnight in-laboratory polysomnography.

    Measured: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.

  9. Change in airway collapsibility (Quetiapine night vs. placebo night)

    Vpassive (% eupnea) during overnight in-laboratory polysomnography.

    Measured: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.

  10. Change in pharyngeal muscle response (Quetiapine night vs. placebo night)

    Vcompensation (% eupnea) during overnight in-laboratory polysomnography.

    Measured: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.

  11. Baseline OSA endotypes (outcomes 8-11) and whether they are associated with changes in OSA severity (Quetiapine night vs. placebo night)

    Exploratory analysis to determine if baseline OSA endotypes (outcomes 8-11) are associated with changes in OSA severity (Quetiapine night vs. placebo night)

    Measured: Baseline sleep study

  12. Change in perceived sleepiness (Quetiapine night vs. placebo night)

    Next day perceived sleepiness assessed via the Karolinska Sleepiness Scale (10 point scale where 1=extremely alert and 10=extremely sleepy)

    Measured: Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.

  13. Change in driving simulator performance (Quetiapine night vs. placebo night)

    Next day alertness as measured via the AusEd driving simulator performance task

    Measured: Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.

  14. Change in psycho-motor vigilance (Quetiapine night vs. placebo night)

    Next day alertness as measured via the pschomotor vigilance test (PVT)

    Measured: Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start25 May 2022
  3. Primary completion4 Apr 2023
  4. Study completion4 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Double-blind, randomized, placebo-controlled, cross-over study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05303935
Sponsor's protocol ID
4965
Acronym
QOSA
Status last verified
Jul 2023
First submitted
24 Feb 2022
Last updated
6 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 31556541

  • 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.

    PubMed 30359361

  • 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.

    PubMed 25485247

  • 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.

    PubMed 15029469

  • 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.

    PubMed 28093029

  • 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.

    PubMed 34214960

  • 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.

    PubMed 34229295

  • 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.

    PubMed 31300334

  • 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.

    PubMed 28110857

  • 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.

    PubMed 23721582

  • 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.

    PubMed 33965721

  • 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.

    PubMed 21269278

  • 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.

    PubMed 28707161

  • 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.

    PubMed 10450601

  • Fauska C, Bastiampillai T, Rawson G, Toson B, Vakulin A, Adams R, Wittert G, Loffler KA, Eckert DJ. Quetiapine modestly improves sleep and breathing but impairs next day performance in people with OSA and difficulty maintaining sleep: A randomized controlled trial. Ann Am Thorac Soc. 2026 Apr 10:aaoag092. doi: 10.1093/annalsats/aaoag092. Online ahead of print.

    PubMed 41968099

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Quetiapine 50 MG in people with Sleep Apnea, Obstructive, run by Flinders University at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05303935, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.

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