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

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Flinders University
• Treatments: Quetiapine Fumarate

Criteria

Inclusion Criteria:

• Ages: 18 to 70 years (Adult, Older Adult)

• Gender: All

• Moderate or more "difficulty staying asleep" score on the Insomnia Severity Index questionnaire

• Mild to moderate OSA

• 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