CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Quetiapine 50 MG +1 moredrug
Likely dose
Quetiapine 50 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05303935
NCT05303935Phase 2Completed

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

Flinders University·interventional·Posted Mar 31, 2022·Updated Jul 6, 2023

In Brief

A Phase 2 clinical trial evaluating Quetiapine 50 MG and Placebo for Sleep Apnea, Obstructive. Completed, enrolled 15 participants across 1 site.

Detailed 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. 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedMar 31, 2022
Enrollment StartMay 25, 2022
Primary CompletionApr 4, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.3 years ago

Interventions

Quetiapine 50 MGdrug

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

Placebodrug

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