The Merge Study version1.0
Research type
Research Study
Full title
Assessment of the effect of Positive Airway Pressure on energy and vitality in mild Obstructive Sleep Apnea patients. The Merge Study
IRAS ID
202827
Contact name
Mary Morrell
Contact email
Sponsor organisation
ResMed (UK) Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 30 days
Research summary
Obstructive sleep apnea (OSA) occurs when the upper airway partially or completely collapses during sleep. OSA is classified as either: severe, moderate or mild depending on how many obstructions occur per hour. The treatment of choice of OSA is Continuous Positive Airway Pressure (CPAP). Moderate and severe OSA have been associated with a number of negative health consequences and daytime symptoms. Effective treatment with CPAP has been shown to improve symptoms and reduce health risks in these patients. The effects of mild OSA are less well understood, and indeed the best treatment for these patients is not clear.
In 2012 the American Academy of Sleep Medicine (AASM) updated the rules for scoring OSA. The new rules included a more relaxed definition of hypopnoeas (partial upper airway closure), which significantly increases the number of patients who can now be diagnosed with OSA. The AASM took this decision because they felt there was growing evidence of the daytime symptoms of these patients, and they should not be denied treatment if it would beneficial. However, to date there is no evidence that treatment of mild OSA using the AASM 2012 criteria is beneficial to patients.
Therefore, this study aims to compare CPAP treatment to standard care in mild OSA patients (as per AASM 2012) in order to better understand the impact of treatment on quality of life in these patients.
Patients will be enrolled and randomised to either standard care (sleep hygiene counselling), or CPAP treatment for a three month period. Changes in quality of life using standardised questionnaires will be compared from baseline to three months post CPAP initiation compared with controls in patients with mild OSA.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
16/SC/0387
Date of REC Opinion
17 Aug 2016
REC opinion
Further Information Favourable Opinion