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

July 4, 2023 updated by: Professor Danny Eckert, Flinders University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5042
        • Adelaide Institute for Sleep Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
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.
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
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.
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
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.
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
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.
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
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.
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
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.
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
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.
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
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.
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
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.
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
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)
Baseline sleep study
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)
Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
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
Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
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)
Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Flinders University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Danny Eckert, PhD, Flinders University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 25, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 4, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 4, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4965

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Time Frame

At conclusion of study and related publications.

IPD Sharing Access Criteria

IPD may be shared for research purposes on application to the chief investigator and subject to applicable ethical review.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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