A Phase 2 interventional study of Quetiapine 50 MG and Placebo in Sleep Apnea, Obstructive, sponsored by Flinders University. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-06.
Sponsored by Flinders University · Phase 2, Interventional, and Other
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.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's enrollment of 15 is below the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Flinders University is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Quetiapine 50mg in the form of one capsule, taken before bedtime. Dosage is taken on one instance for one night only.
Drug: Quetiapine 50 MG
Placebo sugar pill in the form of one capsule, taken before bedtime. Dosage is taken on one instance for one night only.
Drug: Placebo
A single dose of 50mg of quetiapine taken at bedtime for one night.
Also known as: Seroquel
A placebo sugar pill that looks like the quetiapine tablet taken at bedtime for one night.
Also known as: Sugar pill
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.
Time frame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
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.
Time frame: 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)
Mean overnight oxygen saturation during sleep (%) measured via pulse oximetry during overnight in-laboratory polysomnography.
Time frame: 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)
Percent time asleep spent below an arterial oxygen saturation of 90% measured via pulse oximetry during overnight in-laboratory polysomnography.
Time frame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
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.
Time frame: 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)
Number of cortical arousals per hour of sleep during overnight in-laboratory polysomnography.
Time frame: 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)
Proportion of sleep stages (% total sleep time) during overnight in-laboratory polysomnography.
Time frame: 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)
Loop gain and the ventilatory response to arousal (% eupnea) during overnight in-laboratory polysomnography.
Time frame: 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)
Threshold to arousal (% eupnea) during overnight in-laboratory polysomnography.
Time frame: 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)
Vpassive (% eupnea) during overnight in-laboratory polysomnography.
Time frame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
Change in pharyngeal muscle response (Quetiapine night vs. placebo night)
Vcompensation (% eupnea) during overnight in-laboratory polysomnography.
Time frame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
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)
Time frame: Baseline sleep study
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)
Time frame: Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
Change in driving simulator performance (Quetiapine night vs. placebo night)
Next day alertness as measured via the AusEd driving simulator performance task
Time frame: Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
Change in psycho-motor vigilance (Quetiapine night vs. placebo night)
Next day alertness as measured via the pschomotor vigilance test (PVT)
Time frame: Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
Plan to share: 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.
Supporting information: Study protocol, Informed consent form
Time frame: At conclusion of study and related publications.
Access criteria: IPD may be shared for research purposes on application to the chief investigator and subject to applicable ethical review.
Ran from May 2022 to primary completion in Apr 2023, 10 months.
Of 47 phase 2 interventional studies under Sleep Apnea, Obstructive, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 46. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Quetiapine
Flinders University