Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001310459
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
3/11/2025
Date registered
Help: Date registered
26/11/2025
Date last updated
Help: Date last updated
1/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
26/11/2025
Date results provided
Help: Date results provided
1/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
DREAMS: Detection of nocturnal Respiratory Events AMong people living with Schizophrenia.
Scientific title
DREAMS: Detection of nocturnal Respiratory Events AMong people living with Schizophrenia: A randomised non-inferiority trial of the effectiveness and cost benefits of 3 nights of home oximetry compared to standard polysomnography for the diagnosis of sleep apnoea.
Additional trial identifiers [1] 315786 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
DREAMS
Related trial records

Health condition
Health condition(s) studied:
Schizophrenia 339536 0
Obstructive sleep apnoea 339537 0
Condition category
Condition code
Mental Health 335780 335780 0 0
Schizophrenia
Respiratory 335781 335781 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
3 consecutive nights of home and patient administered wrist oximetry (Nonin WristOx2 Model 3150 ARTG Listing https://www.tga.gov.au/resources/artg/322415) for the diagnosis of sleep apnea. The strategy used to assess or monitor adherence or fidelity to the intervention will be a sleep technician will download the data from the machine to determine whether it was used and for how long after it is returned and this cannot be done remotely. Patients are provided with written instructions on how to fit and run the device at home and verbal clinical instruction from a sleep physician.
Intervention code [1] 332412 0
Diagnosis / Prognosis
Description of the comparator or control
One night of Polysomnography in a sleep laboratory as described in the medicare schedule for item 12203 for the diagnosis of sleep apnoea. Equipment is fitted by a sleep technician at the clinical site and data are later scored by a sleep technician and interpreted and reported by a sleep physician. Patients are provided with written instructions on how to present to the sleep laboratory individualised for that sleep laboratory as part of routine clinical care and how to prepare. Data quality are checked by the sleep technician and sleep physician.
Control group
Active

Outcomes
Primary outcome [1] 343315 0
AQol-8D (Quality of life) measure being measured at 1 year post randomisation.
Timepoint [1] 343315 0
12 months post randomisation
Primary outcome [2] 343316 0
Cost-effectiveness analysis over 1 year facilitated by the calculation of Quality Adjusted Life Years (QALYs) from the AQol-8D.
Timepoint [2] 343316 0
The 12 month period following randomisation
Secondary outcome [1] 453967 0
Clinical Global Impression - Change
Timepoint [1] 453967 0
At 12 months but using information in the statistical model from 2 months assessment
Secondary outcome [2] 453968 0
Epworth Sleepiness Scale (Self reported sleepiness in common situations)
Timepoint [2] 453968 0
At 12 months but using information in the statistical model from 2 months assessment
Secondary outcome [3] 453969 0
HbA1c Glycated haemoglobin
Timepoint [3] 453969 0
Closest value clinically recorded to 12 months post randomisation but using information in the statistical model from closest value recorded to 2 months post randomisation
Secondary outcome [4] 453970 0
Total fasting cholesterol
Timepoint [4] 453970 0
Closest value clinically recorded to 12 months post randomisation but using information in the statistical model from closest value recorded to 2 months post randomisation
Secondary outcome [5] 453971 0
Functional outcomes of sleepiness questionnaire (10 item version AKA FOSQ10
Timepoint [5] 453971 0
At 12 months but using information in the statistical model from 2 months assessment
Secondary outcome [6] 453972 0
Cost log to facilitate health economic analyses from the perspective of the state governments, federal Australian healthcare system and society.
Timepoint [6] 453972 0
The 12 months after randomisation

Eligibility
Key inclusion criteria
1. Diagnosis of schizophrenia or schizoaffective disorder recorded in medical records and under the care of a psychiatry service where one of our investigator psychiatrists practices.
2. Clinical suspicion of sleep apnoea or a StopBANG questionnaire score >=4 points
3. Able to provide informed written consent
4. Fluent English literacy
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Previous or current treatment for sleep apnea within the last year (including a surgical procedure aimed at addressing sleep apnea within the last year). Includes CPAP, Mandibular advancement splints, Hyperglossal nerve stimulators. Does not include internet or pharmacy sourced anti-snoring mouthguards.
2. Previous diagnosis or exclusion of sleep apnea within the last year based on any objective testing including polysomnography or overnight pulse oximetry and without major weight gain (i.e. >5%) in the opinion of the referring psychiatrist.
3. Any concomitant disease or condition that according to the investigator’s assessment makes the patients unsuitable for study participation

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analyses will be performed according to the intention to test principle: that is, all eligible randomised participants will be included and analysed according to the study arm to which they were randomised, regardless of interventions or tests received. Methods of accounting for missing data will be described in the statistical analysis plan.
The primary Outcome and Continuous secondary outcomes will be analysed using mixed model analyses of variance (PROC MIXED procedure in the latest version of SAS). Participants and sites will be classed as random effects and diagnostic test (two tests: polysomnography versus 3-nights home oximetry) and time (two time points: 2 and 12 months) as fixed effects. The effect size will be calculated inside a treatment-by-time interaction using the least square means procedure at the primary end point of twelve months. We will allow our mixed model to handle any missing data. Baseline values of outcomes will be entered as co-variates.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/02/2026
Actual
7/07/2026
Date of last participant enrolment
Anticipated
24/12/2027
Actual
Date of last data collection
Anticipated
22/12/2028
Actual
Sample size
Target
140
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 28758 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 28759 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 28760 0
Concord Repatriation Hospital - Concord
Recruitment hospital [4] 28761 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 28763 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 44990 0
2031 - Randwick
Recruitment postcode(s) [2] 44991 0
2050 - Camperdown
Recruitment postcode(s) [3] 44992 0
2139 - Concord
Recruitment postcode(s) [4] 44993 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 44995 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 320212 0
Government body
Name [1] 320212 0
Australian Department of Health, Disability and Ageing, Medical Research Future Fund (MRFF)
Country [1] 320212 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Country
Australia
Secondary sponsor category [1] 322777 0
Other
Name [1] 322777 0
Woolcock Institute for Medical Research
Address [1] 322777 0
Country [1] 322777 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318753 0
Sydney Local Health District HREC – Concord Repatriation General Hospital
Ethics committee address [1] 318753 0
Ethics committee country [1] 318753 0
Australia
Date submitted for ethics approval [1] 318753 0
03/11/2025
Approval date [1] 318753 0
01/07/2026
Ethics approval number [1] 318753 0
2025/ETH02462

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

Contacts
Principal investigator
Name 145154 0
Prof Ron Grunstein
Address 145154 0
Woolcock Institute for Medical Research 2 Innovation Rd North Ryde 2109 NSW
Country 145154 0
Australia
Phone 145154 0
+61 2 9805 3290
Fax 145154 0
Email 145154 0
[email protected]
Contact person for public queries
Name 145155 0
Prof Nathaniel Marshall
Address 145155 0
Woolcock Institute for Medical Research 2 Innovation Rd North Ryde 2109 NSW
Country 145155 0
Australia
Phone 145155 0
+61 2 9805 3000
Fax 145155 0
Email 145155 0
[email protected]
Contact person for scientific queries
Name 145156 0
Prof Nathaniel Marshall
Address 145156 0
Woolcock Institute for Medical Research 2 Innovation Rd North Ryde 2109 NSW
Country 145156 0
Australia
Phone 145156 0
+61 2 9805 3000
Fax 145156 0
Email 145156 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Health economic analyses
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
A finite period of: 15 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Ethical approval and the agreement of the data custodian/s (Ron Grunstein and Nat Marshall)



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval  [email protected]
Informed consent form  [email protected]
Statistical analysis plan  [email protected]
Study protocol  [email protected]


Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.