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

ResMed

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Continous Positive Airway Pressure; Other: Control Group

Study type: Interventional

Funder types: Industry

Identifiers

NCT02699463

MA200216

Details and patient eligibility

About

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.

Full 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.

Enrollment: 301 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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301 participants in 2 patient groups, including a placebo group

Continous Positive Airway Pressure

Active Comparator group

Description:

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

Treatment:

Device: Continous Positive Airway Pressure

Control Group

Placebo Comparator group

Description:

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

Treatment:

Other: Control Group