NCT02699463

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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
OTHER	Control Group	Standard sleep hygiene counseling as per published guidelines

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-05-01
• Completion: 2019-08-01
• First posted: 2016-03-04
• Last updated: 2021-01-26
• Results posted: 2021-01-26

Locations

11 sites across 1 country: United Kingdom