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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05303935




Registration number
NCT05303935
Ethics application status
Date submitted
24/02/2022
Date registered
31/03/2022

Titles & IDs
Public title
Effects of Quetiapine on Sleep and Next Day Alertness in People With Obstructive Sleep Apnea
Scientific title
Effects of Quetiapine on Sleep and Next Day Alertness in People With Obstructive Sleep Apnea
Secondary ID [1] 0 0
4965
Universal Trial Number (UTN)
Trial acronym
QOSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Apnea, Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Quetiapine 50 MG
Treatment: Drugs - Placebo

Experimental: Quetiapine - Quetiapine 50mg in the form of one capsule, taken before bedtime. Dosage is taken on one instance for one night only.

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.


Treatment: Drugs: Quetiapine 50 MG
A single dose of 50mg of quetiapine taken at bedtime for one night.

Treatment: Drugs: Placebo
A placebo sugar pill that looks like the quetiapine tablet taken at bedtime for one night.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in OSA severity (Quetiapine night vs. placebo night)
Timepoint [1] 0 0
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
Secondary outcome [1] 0 0
Change in nadir overnight hypoxemia (Quetiapine night vs. placebo night)
Timepoint [1] 0 0
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
Secondary outcome [2] 0 0
Change in mean overnight hypoxemia (Quetiapine night vs. placebo night)
Timepoint [2] 0 0
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
Secondary outcome [3] 0 0
Change in time below 90% blood arterial oxygen saturation (Quetiapine night vs. placebo night)
Timepoint [3] 0 0
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
Secondary outcome [4] 0 0
Change in sleep efficiency (Quetiapine night vs. placebo night)
Timepoint [4] 0 0
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
Secondary outcome [5] 0 0
Change in arousal index (Quetiapine night vs. placebo night)
Timepoint [5] 0 0
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
Secondary outcome [6] 0 0
Change in sleep architecture (Quetiapine night vs. placebo night)
Timepoint [6] 0 0
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
Secondary outcome [7] 0 0
Change in respiratory control (Quetiapine night vs. placebo night)
Timepoint [7] 0 0
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
Secondary outcome [8] 0 0
Change in the respiratory arousal threshold (Quetiapine night vs. placebo night)
Timepoint [8] 0 0
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
Secondary outcome [9] 0 0
Change in airway collapsibility (Quetiapine night vs. placebo night)
Timepoint [9] 0 0
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
Secondary outcome [10] 0 0
Change in pharyngeal muscle response (Quetiapine night vs. placebo night)
Timepoint [10] 0 0
Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
Secondary outcome [11] 0 0
Baseline OSA endotypes (outcomes 8-11) and whether they are associated with changes in OSA severity (Quetiapine night vs. placebo night)
Timepoint [11] 0 0
Baseline sleep study
Secondary outcome [12] 0 0
Change in perceived sleepiness (Quetiapine night vs. placebo night)
Timepoint [12] 0 0
Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
Secondary outcome [13] 0 0
Change in driving simulator performance (Quetiapine night vs. placebo night)
Timepoint [13] 0 0
Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
Secondary outcome [14] 0 0
Change in psycho-motor vigilance (Quetiapine night vs. placebo night)
Timepoint [14] 0 0
Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/04/2023
Sample size
Target
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Adelaide Institute for Sleep Health - Adelaide
Recruitment postcode(s) [1] 0 0
5042 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
Flinders University
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Danny Eckert, PhD
Address 0 0
Flinders University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Informed consent form (ICF)
When will data be available (start and end dates)?
At conclusion of study and related publications.
Available to whom?
IPD may be shared for research purposes on application to the chief investigator and subject to applicable ethical review.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05303935