Assessment of the Effect of PAP on Energy and Vitality in Mild OSA Patients: The Merge Study
Assessment of the Effect of Positive Airway Pressure on Energy and Vitality in Mild Obstructive Sleep Apnea Patients: The Merge Study
1 other identifier
interventional
301
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2016
Typical duration for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 4, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedResults Posted
Study results publicly available
January 26, 2021
CompletedJanuary 26, 2021
January 1, 2021
2.4 years
March 1, 2016
December 4, 2020
January 6, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Quality of Life Using the Energy and Vitality Subscale of the Short Form 36 (SF-36) Questionnaire
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.
3 months
Study Arms (2)
Continous Positive Airway Pressure
ACTIVE COMPARATORParticipants in this group will use CPAP therapy, nightly, for the 3 month duration of the trial
Control Group
PLACEBO COMPARATORParticipants will receive standard care (Sleep hygiene counseling) during the study.
Interventions
CPAP refers to the application of positive airway pressure through a mask and tubing to splint a patients throat open at night. CPAP is considered standard treatment for OSA
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ResMedlead
Study Sites (11)
Freeman Hospital
Newcastle upon Tyne, Newcastle, United Kingdom
Blackpool Teaching Hospital
Blackpool, United Kingdom
Papworth Hospital
Cambridge, United Kingdom
Tayside Health Board, Ninewells Hospital
Dundee, United Kingdom
Aintree University Hospital
Liverpool, United Kingdom
Royal Brompton Hospital, Imperial College London
London, SW3 6NP, United Kingdom
Guys & St Thomas Hospital
London, United Kingdom
Oxford Centre for Respiratory Medicine
Oxford, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Lister Hospital
Stevenage, United Kingdom
Taunton and Somerset Hospital
Taunton, United Kingdom
Related Publications (1)
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.
PMID: 31806413DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Alison Wimms
- Organization
- ResMed Ltd
Study Officials
- PRINCIPAL INVESTIGATOR
Mary Morrell, Prof
Imperial College London
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2016
First Posted
March 4, 2016
Study Start
December 1, 2016
Primary Completion
May 1, 2019
Study Completion
August 1, 2019
Last Updated
January 26, 2021
Results First Posted
January 26, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share