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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Health Services Research
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
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
Other
Name [1] 0 0
Lyell McEwin Hospital
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The prevalence of anxiety and depression in our OSA population is more than in COPD and the
general population of North West Adelaide. (principal hypothesis).

CPAP therapy in OSA population produces a positive effect on the anxiety and depression
scale.

The Investigators intend to study the prevalence of anxiety and depression in patients with
sleep disorders in comparison to patients with COPD and subsequently, to assess whether CPAP
has a role in controlling anxiety and depression in depressed and anxious patients with sleep
apnoea.

This is a two phase study, in first phase; investigator will assess the prevalence of anxiety
and depression, in a population with sleep disorders to check whether it is different to the
prevalence in the COPD population. The prevalence of depression in Sleep Disorder population
will also be compared with the Adelaide North Western general population, which was reported
in The North West Adelaide Health Study. According to this epidemiological survey, which was
conducted from 2008 to 2010, the prevalence of depression in Adelaide North Western general
population was 20%.During the second phase of the study investigator will evaluate the effect
of CPAP on anxiety and depression scores in the depressed and anxious patients with sleep
apnoea by comparing the pre and post CPAP anxiety and depression status. The Hospital Anxiety
and Depression (HAD) scale will be used to assess Anxiety and Depression, which is a
well-documented tool for assessing symptoms of anxiety and depression in patients with
somatic diseases.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01985347
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01985347