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

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ClinicalTrials.gov Identifier: NCT05303935
Recruitment Status : Recruiting
First Posted : March 31, 2022
Last Update Posted : August 30, 2022
Sponsor:
Information provided by (Responsible Party):
Professor Danny Eckert, Flinders University

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Double-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
Actual Study Start Date : May 25, 2022
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
Drug Information available for: Quetiapine

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 Name: 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 Name: Sugar pill




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05303935


Contacts
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Contact: Carolin Tran 087421 9873 ext +61 carolin.tran@flinders.edu.au
Contact: Kelly Loffler 08 7221 8314 ext +61 kelly.loffler@flinders.edu.au

Locations
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Australia, South Australia
Adelaide Institute for Sleep Health Recruiting
Adelaide, South Australia, Australia, 5042
Contact: Carolin Tran    874219873 ext +61    carolin.tran@flinders.edu.au   
Principal Investigator: Danny Eckert         
Sponsors and Collaborators
Flinders University
Investigators
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Principal Investigator: Danny Eckert, PhD Flinders University
Additional Information:
Publications:

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Responsible Party: Professor Danny Eckert, Director, Adelaide Institute for Sleep Health, Flinders University
ClinicalTrials.gov Identifier: NCT05303935    
Other Study ID Numbers: 4965
First Posted: March 31, 2022    Key Record Dates
Last Update Posted: August 30, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participants will be informed in plain language through the consent form that their deidentified data may be made available to other researchers. Deidentified participant data will only be shared with other researchers upon request to the chief investigator after study publication and subject to ethical approval.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: At conclusion of study and related publications.
Access Criteria: IPD may be shared for research purposes on application to the chief investigator and subject to applicable ethical review.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Professor Danny Eckert, Flinders University:
Sleep apnea, obstructive
quetiapine
randomised
double-blind
placebo
respiratory arousal threshold
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs