Positive Airway Pressure plus Mandibular Advancement Therapy (PAPMAT)
Research type
Research Study
Full title
MAD plus CPAP: does combining two established treatments for Obstructive Sleep Apnoea give added benefits?
IRAS ID
296163
Contact name
Tim Quinnell
Contact email
Sponsor organisation
Royal Papworth Hospital NHS Foundation Trust
ISRCTN Number
ISRCTN33966032
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This is a single-centre, adaptive 2x2 randomised crossover design trial, comparing continuous postive airways pressure (CPAP) therapy with CPAP therapy plus mandibular advancement device (MAD). The study will investigate the following:
1. Does combining MAD with CPAP therapy make it easier for patients to tolerate CPAP: thereby increasing adherence to treatment?
2. Does combining MAD with CPAP therapy reduce CPAP pressure requirements?Patients with moderate to severe obstructive sleep apnoea (OSA) will be approached at their routine CPAP set-up day case appointment, and recruited at their follow-up appointment approximately 6 weeks later. Study participants will be randomised into either standalone CPAP therapy or CPAP+ MAD therapy. After 10 weeks they will switch arms. Data collection will include OSA characteristics and adherence to CPAP, patient demographics, quality of life and sleep assessment questionnaires. There are 3 research visits; visit 1 will be in person, visit 2 can be completed remotely or in person, and visit 3 can be completed remotely if it does not coincide with a routine clinical visit.
Participants will be given the option of continuing with the combination treatment after the end of the trial. If the results of this study show combination treatment to be effective and cost-effective it would be straightforward to introduce this treatment to the wider NHS.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
21/EE/0125
Date of REC Opinion
29 Jun 2021
REC opinion
Further Information Favourable Opinion