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

NCT ID: NCT02699463

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 301 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2019-08-31

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Continous Positive Airway Pressure

Participants in this group will use CPAP therapy, nightly, for the 3 month duration of the trial

Group Type: ACTIVE_COMPARATOR

Continous Positive Airway Pressure

Intervention Type: DEVICE

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

Control Group

Participants will receive standard care (Sleep hygiene counseling) during the study.

Group Type: PLACEBO_COMPARATOR

Control Group

Intervention Type: OTHER

Standard sleep hygiene counseling as per published guidelines

Interventions

Continous Positive Airway Pressure

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

Intervention Type: DEVICE

Control Group

Standard sleep hygiene counseling as per published guidelines

Intervention Type: OTHER

Other Intervention Names

CPAP

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ResMed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Morrell, Prof

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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, , 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

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 31806413 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MA200216

Identifier Type: -

Identifier Source: org_study_id