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

NCT02699463 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2021-01-26

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • ResMed

    lead INDUSTRY

Principal Investigators

  • Mary Morrell, Prof · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2019-05-31
Completion
2019-08-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02699463 on ClinicalTrials.gov