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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01985347




Registration number
NCT01985347
Ethics application status
Date submitted
28/10/2013
Date registered
15/11/2013
Date last updated
15/11/2013

Titles & IDs
Public title
The SAD Study - SLEEP, ANXIETY & DEPRESSION Study A Prospective Cohort Study
Scientific title
The SAD Study - SLEEP, ANXIETY & DEPRESSION Study A Prospective Cohort Study
Secondary ID [1] 0 0
HREC/13/TQEHLMH/14
Universal Trial Number (UTN)
Trial acronym
SAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients With Anxiety and Depression, Who Have 0 0
Obstructive Sleep Apnoea 0 0
COPD 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea
Mental Health 0 0 0 0
Depression
Mental Health 0 0 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - CPAP

Active comparator: Obstructive Sleep Apnoea - Patients with newly diagnosed obstructive sleep apnoea and who have anxiety and depression would be given continuous positive airway pressure (CPAP) treatment.

No intervention: Chronic obstructive pulmonary disease and western population - (For this group no intervention needed).Patients with COPD, who have anxiety and depression \& normal population in Western Adelaide who also have anxiety and depression their prevalence would be compare with patients of Obstructive sleep apnoea.


Treatment: Devices: CPAP
Continuous positive airway pressure( CPAP)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To establish the prevalence of anxiety and depression in patients with sleep disorders and compare how this prevalence differs from its prevalence in COPD and in the general population.
Timepoint [1] 0 0
24weeks
Secondary outcome [1] 0 0
To evaluate whether treatment with CPAP improves anxiety and depression symptoms (HAD scale) at 3 and 12 months in OSA patients with anxiety and depression.
Timepoint [1] 0 0
24 months

Eligibility
Key inclusion criteria
* Patients attending the Respiratory and Sleep Outpatient Clinics at LMH and TQEH with OSA or COPD
* Aged over 18 years
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unwilling or unable to give informed written consent

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2015
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5011 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
The Queen Elizabeth Hospital
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Lyell McEwin Hospital
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Faisal Ameer
Address 0 0
The Queen Elizabeth Hospital
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

No information has been provided regarding IPD availability


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/NCT01985347