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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01985347
Acronym
SAD
Enrollment
500
Registered
2013-11-15
Start date
2013-11-30
Completion date
2015-03-31
Last updated
2013-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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 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.

Interventions

DEVICECPAP

Continuous positive airway pressure( CPAP)

Sponsors

Lyell McEwin Hospital
CollaboratorOTHER_GOV
The Queen Elizabeth Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026