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The SAD Study - SLEEP, ANXIETY & DEPRESSION Study A Prospective Cohort Study (SAD)

Primary Purpose

Patients With Anxiety and Depression, Who Have, Obstructive Sleep Apnoea, COPD

Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
CPAP
Sponsored by
The Queen Elizabeth Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Patients With Anxiety and Depression, Who Have

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients attending the Respiratory and Sleep Outpatient Clinics at LMH and TQEH with OSA or COPD
  • Aged over 18 years

Exclusion Criteria:

  • Unwilling or unable to give informed written consent

Sites / Locations

  • The Queen Elizabeth Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Obstructive Sleep Apnoea

Chronic obstructive pulmonary disease and western population

Arm Description

Patients with newly diagnosed obstructive sleep apnoea and who have anxiety and depression would be given continuous positive airway pressure (CPAP) treatment.

(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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 28, 2013
Last Updated
November 8, 2013
Sponsor
The Queen Elizabeth Hospital
Collaborators
Lyell McEwin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01985347
Brief Title
The SAD Study - SLEEP, ANXIETY & DEPRESSION Study A Prospective Cohort Study
Acronym
SAD
Official Title
The SAD Study - SLEEP, ANXIETY & DEPRESSION Study A Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Queen Elizabeth Hospital
Collaborators
Lyell McEwin Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
AIM (S) / OBJECTIVE OF STUDY To compare the prevalence of anxiety and depression in patients with sleep disorders (OSA), COPD and the general population of North West Adelaide. To study the effect of CPAP on depression and anxiety in patients with sleep apnoea who also have anxiety and depression. STUDY DESIGN/ SETTING/LOCATION/POPULATION This is a multicenter Prospective Cohort study run at the Lyell McEwin Hospital (LMH) and The Queen Elizabeth Hospital (TQEH), among patients attending the Respiratory and Sleep Outpatient Clinics at the Lyell McEwin Hospital (LMH) and The Queen Elizabeth Hospital (TQEH). These both sites are teaching tertiary hospital. STUDY OUTCOMES Primary Outcome 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. Secondary Outcome 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Anxiety and Depression, Who Have, Obstructive Sleep Apnoea, COPD

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Obstructive Sleep Apnoea
Arm Type
Active Comparator
Arm Description
Patients with newly diagnosed obstructive sleep apnoea and who have anxiety and depression would be given continuous positive airway pressure (CPAP) treatment.
Arm Title
Chronic obstructive pulmonary disease and western population
Arm Type
No Intervention
Arm Description
(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.
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
Continuous positive airway pressure( CPAP)
Primary Outcome Measure Information:
Title
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.
Time Frame
24weeks
Secondary Outcome Measure Information:
Title
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients attending the Respiratory and Sleep Outpatient Clinics at LMH and TQEH with OSA or COPD Aged over 18 years Exclusion Criteria: Unwilling or unable to give informed written consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faisal Ameer
Organizational Affiliation
The Queen Elizabeth Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Queen Elizabeth Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ameer
Phone
0061-8-82226000
Email
faisal.ameer@health.sa.gov
First Name & Middle Initial & Last Name & Degree
Faisal Ameer

12. IPD Sharing Statement

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The SAD Study - SLEEP, ANXIETY & DEPRESSION Study A Prospective Cohort Study

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