Clinical trial NCT02699463: Assessment of the Effect of PAP on Energy and Vitality in Mild OSA Patients: The Merge Study
Official title: Assessment of the Effect of Positive Airway Pressure on Energy and Vitality in Mild Obstructive Sleep Apnea Patients: The Merge Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2016-03-04
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Study Inclusion Criteria

* Aged ≥ 18 and ≤ 80
* Ability and willingness to provide written informed consent
* AHI ≤ 15 as per AASM 2007 scoring criteria
* Ability to tolerate a CPAP one hour long run in test

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

Primary outcomes:
measure: Change in Quality of Life Using the Energy and Vitality Subscale of the Short Form 36 (SF-36) Questionnaire
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
state: Newcastle
city: Blackpool
country: United Kingdom
facility: Blackpool Teaching Hospital
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
city: Dundee
country: United Kingdom
facility: Tayside Health Board, Ninewells Hospital
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital
city: London
country: United Kingdom
facility: Royal Brompton Hospital, Imperial College London
city: London
country: United Kingdom
facility: Guys & St Thomas Hospital
city: Oxford
country: United Kingdom
facility: Oxford Centre for Respiratory Medicine
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Stevenage
country: United Kingdom
facility: Lister Hospital
city: Taunton
country: United Kingdom
facility: Taunton and Somerset Hospital
Study officials:
affiliation: Imperial College London
name: Mary Morrell, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wimms AJ, Kelly JL, Turnbull CD, McMillan A, Craig SE, O'Reilly JF, Nickol AH, Hedley EL, Decker MD, Willes LA, Calverley PMA, Benjafield AV, Stradling JR, Morrell MJ; MERGE trial investigators. Continuous positive airway pressure versus standard care for the treatment of people with mild obstructive sleep apnoea (MERGE): a multicentre, randomised controlled trial. Lancet Respir Med. 2020 Apr;8(4):349-358. doi: 10.1016/S2213-2600(19)30402-3. Epub 2019 Dec 2.