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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Freeman Hospital, Newcastle upon Tyne, Newcastle, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continous Positive Airway Pressure

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

Other names: CPAP

Control Group

Other

Standard sleep hygiene counseling as per published guidelines

Primary outcomes

Change in Quality of Life Using the Energy and Vitality Subscale of the Short Form 36 (SF-36) Questionnaire

Time frame: 3 months

The Short Form 36 (SF-36) questionnaire measures quality of life through a range of questions asking about patients physical and mental functioning. Specifically, the Energy and Vitality subscale records patients perceptions of their levels of energy and fatigue. Participants were administered the Short Form 36 (SF-36) questionnaire at baseline and 3 months. The change in score (value at 3 months minus value at baseline) was compared between the CPAP group and the Control group.

In the SF-36 Energy and Vitality subscale, an increase in score indicates improvement, with a minimum score of 0 and a maximum score of 100 possible.

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

Assessment of the Effect of Positive Airway Pressure on Energy and Vitality in Mild Obstructive Sleep Apnea Patients: The Merge Study

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Mar 4, 2016
Registry last updated: Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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