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

COPD Clinical Trial

— SAD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01985347
• Other study ID #: HREC/13/TQEHLMH/14
• Status: Not yet recruiting
• Phase: N/A
• First received: October 28, 2013
• Last updated: November 8, 2013
• Start date: November 2013
• Est. completion date: March 2015

Study information

• Verified date: November 2013
• Source: The Queen Elizabeth Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Anxiety Disorders
• COPD
• Depression
• Depressive Disorder
• Obstructive Sleep Apnoea
• Patients With Anxiety and Depression, Who Have
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP
Continuous positive airway pressure( CPAP)

Locations

Country	Name	City	State
Australia	The Queen Elizabeth Hospital	Adelaide	South Australia

Sponsors (2)

Lead Sponsor	Collaborator
The Queen Elizabeth Hospital	Lyell McEwin Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No