Clinical trial NCT05303935: Effects of Quetiapine on Sleep and Next Day Alertness in People With Obstructive Sleep Apnea
Official title: Effects of Quetiapine on Sleep and Next Day Alertness in People With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sleep Apnea, Obstructive
Keywords: Sleep apnea, obstructive
quetiapine
randomised
double-blind
placebo
respiratory arousal threshold
Lead sponsor: Flinders University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blind, randomized, placebo-controlled, cross-over study
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in OSA severity (Quetiapine night vs. placebo night)
timeFrame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
Secondary outcomes:
measure: Change in nadir overnight hypoxemia (Quetiapine night vs. placebo night)
timeFrame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
measure: Change in mean overnight hypoxemia (Quetiapine night vs. placebo night)
timeFrame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
measure: Change in time below 90% blood arterial oxygen saturation (Quetiapine night vs. placebo night)
timeFrame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
measure: Change in sleep efficiency (Quetiapine night vs. placebo night)
timeFrame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
measure: Change in arousal index (Quetiapine night vs. placebo night)
timeFrame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
measure: Change in sleep architecture (Quetiapine night vs. placebo night)
timeFrame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
measure: Change in respiratory control (Quetiapine night vs. placebo night)
timeFrame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
measure: Change in the respiratory arousal threshold (Quetiapine night vs. placebo night)
timeFrame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
measure: Change in airway collapsibility (Quetiapine night vs. placebo night)
timeFrame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
measure: Change in pharyngeal muscle response (Quetiapine night vs. placebo night)
timeFrame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
measure: Baseline OSA endotypes (outcomes 8-11) and whether they are associated with changes in OSA severity (Quetiapine night vs. placebo night)
timeFrame: Baseline sleep study
measure: Change in perceived sleepiness (Quetiapine night vs. placebo night)
timeFrame: Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
measure: Change in driving simulator performance (Quetiapine night vs. placebo night)
timeFrame: Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
measure: Change in psycho-motor vigilance (Quetiapine night vs. placebo night)
timeFrame: Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Adelaide Institute for Sleep Health
state: South Australia
Study officials:
affiliation: Flinders University
name: Danny Eckert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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