Obersvational Study on Effects of CPAP on Depressive Symptoms in OSAS

NCT05953025 | Completed

• 1 other identifier: PHT/2017/65
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The official definition of depression or major depressive disorder, is a psychological disorder which is characterised by a persistent low mood or loss of interest in previously pleasurable activities, for over two weeks. It is one of the leading causes of disability world-wide and is one of the most common mental health disorders, affecting 5-10% of the world population at any one time. However, a major problem with this condition is the over-use of antidepressants. The number of anti-depressant prescriptions has doubled in the last decade and cost the NHS £780,000 per day in 2015. Many of the symptoms of obstructive sleep apnoea syndrome (OSAS) are similar to symptoms of depression, such as fatigue, low mood, difficulty concentrating and un-refreshing sleep. This means that patients could be misdiagnosed with depression and begin on courses of antidepressants which don't improve their symptoms. A very high association between OSAS and depression has been consistently recorded in research studies. Similarly, the primary treatment for OSAS, continuous positive airway pressure (CPAP) has been shown to significantly improve depressive symptoms in these patients. However, when studying the effects CPAP therapy has on patients with OSAS, one of the main factors which can cause differences is in antidepressant use. A lot of studies have excluded those who are on them, while quite a lot failed to note the antidepressant use. Therefore, this study aims to focus on those patients who are on antidepressant therapy but not gaining remission in their symptoms. These patients may be classed as anti-depressant treatment resistant.

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Changes in depressive symptom

  To assess changes in depressive symptoms of patients with OSAS at 6 weeks following CPAP treatment, using the PHQ-9 questionnaire

  Over the course of the entire study- 10 months

Secondary Outcomes (6)

• Describe depressive symptoms

  Over the course of the entire study- 10 months

• Somnolence in the whole cohort

  Over the course of the entire study- 10 months

• Describe fatigue in the cohort

  Over the course of the entire study- 10 months

• Describe OSAS severity

  Over the course of the entire study- 10 months

• Relationships between scores

  Over the course of the entire study- 10 months [response to comment- this study has already completed using these outcome measures- no more updates to this will be made]

Interventions

Questionnaire BEHAVIORAL

No intervention on care- questionnaire to see effect of standard care treatment on symptoms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will have an appointment to attend a consultation in the sleep department of Queen Alexandra Hospital. The majority will be diagnosed with OSAS following a sleep consultation and a home sleep study. They will then be beginning a course of CPAP therapy for the first time.

You may qualify if:

• Male or female
• Aged 18 years or above
• Be treated by the Portsmouth NHS Trust Sleep Department
• Participant is willing and able to give informed consent for participation in the study

You may not qualify if:

• Has a disorder, including cognitive dysfunction, which would impair their ability to accurately complete the questionnaires or provide informed consent
• Unable to read or understand basic English (an interpreter will not be available for this study)

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead

Study Sites (1)

Portsmouth Hospitals NHS Trust

Cosham, Hampshire, PO6 3LY, United Kingdom

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Tess Compton-Price

  Lead Therapist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: July 19, 2023
• Study Start: November 10, 2017
• Primary Completion: August 7, 2018
• Study Completion: August 7, 2018
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)