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Completed

NCT Number: NCT05303935

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

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.

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Adelaide Institute for Sleep Health

Adelaide, South Australia, 5042, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quetiapine 50 MG

Drug

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

Other names: Seroquel

Placebo

Drug

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

Other names: Sugar pill

Primary outcomes

  1. Change in OSA severity (Quetiapine night vs. placebo night)

    Time frame: 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 outcomes

  1. Change in nadir overnight hypoxemia (Quetiapine night vs. placebo night)

    Time frame: 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.

  2. Change in mean overnight hypoxemia (Quetiapine night vs. placebo night)

    Time frame: 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.

  3. Change in time below 90% blood arterial oxygen saturation (Quetiapine night vs. placebo night)

    Time frame: 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.

  4. Change in sleep efficiency (Quetiapine night vs. placebo night)

    Time frame: 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.

  5. Change in arousal index (Quetiapine night vs. placebo night)

    Time frame: 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.

  6. Change in sleep architecture (Quetiapine night vs. placebo night)

    Time frame: 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.

  7. Change in respiratory control (Quetiapine night vs. placebo night)

    Time frame: 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.

  8. Change in the respiratory arousal threshold (Quetiapine night vs. placebo night)

    Time frame: 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.

  9. Change in airway collapsibility (Quetiapine night vs. placebo night)

    Time frame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.

    Vpassive (% eupnea) during overnight in-laboratory polysomnography.

  10. Change in pharyngeal muscle response (Quetiapine night vs. placebo night)

    Time frame: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.

    Vcompensation (% eupnea) during overnight in-laboratory polysomnography.

  11. Baseline OSA endotypes (outcomes 8-11) and whether they are associated with changes in OSA severity (Quetiapine night vs. placebo night)

    Time frame: 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)

  12. Change in perceived sleepiness (Quetiapine night vs. placebo night)

    Time frame: 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)

  13. Change in driving simulator performance (Quetiapine night vs. placebo night)

    Time frame: 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

  14. Change in psycho-motor vigilance (Quetiapine night vs. placebo night)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Flinders University

Other

Registry information

Acronym: QOSA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 31, 2022
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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