N/A Completed N=233 Randomized Treatment

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

Obstructive Sleep Apnea

Source: ClinicalTrials.gov NCT02699463 ↗

Enrolled (actual)

233

Serious AEs

1.3%

Results posted

Jan 2021

Primary outcomePrimary: Change in Quality of Life Using the Energy and Vitality Subscale of the Short Form 36 (SF-36) Questionnaire — 7.5; 0 score on a scale — p=<0.01

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Quality of Life Using the Energy and Vitality Subscale of the Short Form 36 (SF-36) Questionnaire	7.5; 0	<0.01 sig

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT02699463). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.