Assessment of the Effect of PAP on Energy and Vitality in Mild OSA Patients: The Merge Study

Not Applicable

Completed

Interventions: Device: Continous Positive Airway Pressure
Other: Control Group

Brief Summary: The investigators wish to prospectively determine the response to CPAP in patients presenting with mild OSA. In many healthcare systems, patients with mild OSA (AHI 5-15) are not reimbursed for treatment. Although some evidence exists of the benefits of treating mild OSA when scoring as per AASM 2007 criteria, more evidence is needed. The investigators wish to add to this pool of knowledge and also increase the inclusion criteria to include the AASM 2012 definition of mild OSA. By including the 2012 AASM definition of mild OSA, the investigators will add novel information to the field by assessing the benefits of treatment in both sub-groups of mild OSA.

Detailed Description: Patients who visit their local sleep service for OSA investigation, and are found to have mild OSA (AHI ≤ 15) from an Apnealink polygraphy (PG) home sleep test, scored as per AASM 2007 and/or AASM 2012, will be invited to take part in the study (pre-screening).

At the study visit, informed consent, baseline demographics, and standardised questionnaires will be administered. Participants will then be randomised to a CPAP treatment group or control group.

After 3 months, participants will be asked to repeat the standardised questionnaires, the trial will then be complete and they will return to routine clinical care.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

The presence of unstable cardiac disease
Inability to give fully informed consent
Supplemental oxygen
Secondary sleep pathology e.g. Periodic Limb Movement Syndrome, Narcolepsy, Circadian Disorder, obesity hypoventilation syndrome
ESS ≥ 15, or concerns about sleepy driving from physician/ sleep lab staff
BMI ≥ 40

Arm && Interventions

Group	Intervention	Description
Continous Positive Airway Pressure	Continous Positive Airway Pressure	Participants in this group will use CPAP therapy, nightly, for the 3 month duration of the trial
Control Group	Control Group	Participants will receive standard care (Sleep hygiene counseling) during the study.

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life Using the Energy and Vitality Subscale of the Short Form 36 (SF-36) Questionnaire	3 months	The Short Form 36 (SF-36) questionnaire measures quality of life through a range of questions asking about patients physical and mental functioning. Specifically, the Energy and Vitality subscale records patients perceptions of their levels of energy and fatigue. Participants were administered the Short Form 36 (SF-36) questionnaire at baseline and 3 months. The change in score (value at 3 months minus value at baseline) was compared between the CPAP group and the Control group. In the SF-36 Energy and Vitality subscale, an increase in score indicates improvement, with a minimum score of 0 and a maximum score of 100 possible.

Secondary Outcome Measures

Name	Time	Method

Locations (11): Blackpool Teaching Hospital
🇬🇧
Blackpool, United Kingdom
Papworth Hospital
🇬🇧
Cambridge, United Kingdom
Freeman Hospital
🇬🇧
Newcastle upon Tyne, Newcastle, United Kingdom
Guys & St Thomas Hospital
🇬🇧
London, United Kingdom
Aintree University Hospital
🇬🇧
Liverpool, United Kingdom
Taunton and Somerset Hospital
🇬🇧
Taunton, United Kingdom
Tayside Health Board, Ninewells Hospital
🇬🇧
Dundee, United Kingdom
Lister Hospital
🇬🇧
Stevenage, United Kingdom
Royal Brompton Hospital, Imperial College London
🇬🇧
London, United Kingdom
Oxford Centre for Respiratory Medicine
🇬🇧
Oxford, United Kingdom
Derriford Hospital
🇬🇧
Plymouth, United Kingdom