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

NCT01985347 | Unknown DMC

• 1 other identifier: HREC/13/TQEHLMH/14
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Obstructive Sleep Apnoea

ACTIVE COMPARATOR

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

Device: CPAP

Chronic obstructive pulmonary disease and western population

NO INTERVENTION

(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.

Interventions

CPAP DEVICE

Continuous positive airway pressure( CPAP)

Obstructive Sleep Apnoea

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unwilling or unable to give informed written consent

Sponsors & Collaborators

• The Queen Elizabeth Hospital: lead
• Lyell McEwin Hospital: collaborator

Study Sites (1)

The Queen Elizabeth Hospital

Adelaide, South Australia, 5011, Australia

Location

MeSH Terms

Conditions

Depression; Sleep Apnea, Obstructive; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Faisal Ameer

  The Queen Elizabeth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 15, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: November 15, 2013

Record last verified: 2013-11

Locations

AU (1)