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

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.

Study Overview

• Status: Unknown
• Conditions: COPD; Obstructive Sleep Apnoea; Patients With Anxiety and Depression, Who Have
• Intervention / Treatment: Device: CPAP

Detailed Description

AIM (S) / OBJECTIVE OF STUDY

1. To compare the prevalence of anxiety and depression in patients with sleep disorders (OSA), COPD and the general population of North West Adelaide.
2. 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

1. 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.
2. 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.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital
      • Contact: Ameer; Phone Number: 0061-8-82226000; Email: faisal.ameer@health.sa.gov
      • Principal Investigator: Faisal Ameer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: CPAP; Continuous positive airway pressure( CPAP)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	24weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	24 months

Collaborators and Investigators

• Sponsor: The Queen Elizabeth Hospital
• Collaborators: Lyell McEwin Hospital
• Investigators: Principal Investigator: Faisal Ameer, The Queen Elizabeth Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): March 1, 2015

Study Registration Dates

• First Submitted: October 28, 2013
• First Submitted That Met QC Criteria: November 8, 2013
• First Posted (Estimate): November 15, 2013

Study Record Updates

• Last Update Posted (Estimate): November 15, 2013
• Last Update Submitted That Met QC Criteria: November 8, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Mood Disorders; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Depression; Depressive Disorder; Sleep Apnea, Obstructive; Anxiety Disorders
• Other Study ID Numbers: HREC/13/TQEHLMH/14