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

Flinders University

Status and phase: Completed; Phase 2

Conditions: Sleep Apnea, Obstructive

Treatments: Drug: Quetiapine 50 MG; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05303935

4965

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups, including a placebo group

Quetiapine

Experimental group

Description:

Quetiapine 50mg in the form of one capsule, taken before bedtime. Dosage is taken on one instance for one night only.

Treatment:

Drug: Quetiapine 50 MG

Placebo

Placebo Comparator group

Description:

Placebo sugar pill in the form of one capsule, taken before bedtime. Dosage is taken on one instance for one night only.

Treatment:

Drug: Placebo