Clinical trial NCT01985347: The SAD Study - SLEEP, ANXIETY & DEPRESSION Study A Prospective Cohort Study
Official title: The SAD Study - SLEEP, ANXIETY & DEPRESSION Study A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients With Anxiety and Depression, Who Have
Obstructive Sleep Apnoea
COPD
Lead sponsor: The Queen Elizabeth Hospital
Sponsor class: OTHER
Collaborators: name: Lyell McEwin Hospital
First posted: 2013-11-15
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: 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.
timeFrame: 24weeks
Secondary outcomes:
measure: 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.
timeFrame: 24 months
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
Study officials:
affiliation: The Queen Elizabeth Hospital
name: Faisal Ameer
role: PRINCIPAL_INVESTIGATOR
References: