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

Sponsor

Flinders University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05303935

Collaborator

(none)

Enrollment

Location

Arms

32.8

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea, Obstructive	Drug: Quetiapine 50 MG Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Double-blind, randomized, placebo-controlled, cross-over studyDouble-blind, randomized, placebo-controlled, cross-over study

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Apr 7, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Quetiapine 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 A single dose of 50mg of quetiapine taken at bedtime for one night. Other Names: Seroquel
Placebo Comparator: Placebo 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 placebo sugar pill that looks like the quetiapine tablet taken at bedtime for one night. Other Names: Sugar pill

Arm

Intervention/Treatment

Experimental: Quetiapine

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

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

Other Names:

Seroquel

Placebo Comparator: Placebo

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

Other Names:

Sugar pill

Outcome Measures

Primary Outcome Measures

Change in OSA severity (Quetiapine night vs. placebo night) [Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.]
OSA severity as measured by the AHI (apnoea hypopnea index measured as # events/h sleep) during overnight in-laboratory polysomnography.

Secondary Outcome Measures

Change in nadir overnight hypoxemia (Quetiapine night vs. placebo night) [Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.]
Nadir overnight oxygen saturation during sleep (%) measured via pulse oximetry during overnight in-laboratory polysomnography.
Change in mean overnight hypoxemia (Quetiapine night vs. placebo night) [Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.]
Mean overnight oxygen saturation during sleep (%) measured via pulse oximetry during overnight in-laboratory polysomnography.
Change in time below 90% blood arterial oxygen saturation (Quetiapine night vs. placebo night) [Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.]
Percent time asleep spent below an arterial oxygen saturation of 90% measured via pulse oximetry during overnight in-laboratory polysomnography.
Change in sleep efficiency (Quetiapine night vs. placebo night) [Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.]
Percent time spent asleep divided by the recording time from lights out to lights on during overnight in-laboratory polysomnography.
Change in arousal index (Quetiapine night vs. placebo night) [Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.]
Number of cortical arousals per hour of sleep during overnight in-laboratory polysomnography.
Change in sleep architecture (Quetiapine night vs. placebo night) [Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.]
Proportion of sleep stages (% total sleep time) during overnight in-laboratory polysomnography.
Change in respiratory control (Quetiapine night vs. placebo night) [Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.]
Loop gain and the ventilatory response to arousal (% eupnea) during overnight in-laboratory polysomnography.
Change in the respiratory arousal threshold (Quetiapine night vs. placebo night) [Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.]
Threshold to arousal (% eupnea) during overnight in-laboratory polysomnography.
Change in airway collapsibility (Quetiapine night vs. placebo night) [Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.]
Vpassive (% eupnea) during overnight in-laboratory polysomnography.
Change in pharyngeal muscle response (Quetiapine night vs. placebo night) [Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.]
Vcompensation (% eupnea) during overnight in-laboratory polysomnography.
Baseline OSA endotypes (outcomes 8-11) and whether they are associated with changes in OSA severity (Quetiapine night vs. placebo night) [Baseline sleep study]
Exploratory analysis to determine if baseline OSA endotypes (outcomes 8-11) are associated with changes in OSA severity (Quetiapine night vs. placebo night)
Change in perceived sleepiness (Quetiapine night vs. placebo night) [Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.]
Next day perceived sleepiness assessed via the Karolinska Sleepiness Scale (10 point scale where 1=extremely alert and 10=extremely sleepy)
Change in driving simulator performance (Quetiapine night vs. placebo night) [Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.]
Next day alertness as measured via the AusEd driving simulator performance task
Change in psycho-motor vigilance (Quetiapine night vs. placebo night) [Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.]
Next day alertness as measured via the pschomotor vigilance test (PVT)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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