Oral mandibular advancement devices for obstructive sleep apnoea-hypopnoea

Plain English Summary

Background and study aims
Obstructive Sleep Apnoea Hypopnoea (OSAH) involves repetitive narrowing or closure of the upper airway during sleep, which results in reduced breathing (hypopnoea) or paused breathing (apnoea). This abnormal breathing causes oxygen levels to drop and leads to wakening from sleep. Sleep disturbance results in excessive daytime sleepiness, poor concentration, personality changes and irritability. In the long term there is an increased risk of heart disease and stroke in affected individuals. OSAH is a chronic condition that generally requires life-long treatment. Patients with mild OSAH are often treated conservatively with advice on weight loss, alcohol consumption and sleeping position. The standard treatment for people with moderate to severe OSAH is Continuous Positive Airway Pressure (CPAP) where air is blown into the upper airway during sleep, via either a nasal or face mask, to prevent it collapsing. However, some patients are unable to tolerate this treatment. Mild to moderate OSAH can be treated with Mandibular Advancement Devices (MAD) which hold the lower jaw and tongue forward, making more space to breathe. Research evidence indicates that CPAP is more effective than MAD and MAD is better than sham (pretend) MAD for the treatment of OSAH. Two important research questions are not answered: is MAD more effective than no treatment, and is MAD effectiveness related to device complexity? The first question is important because patients using sham MAD are likely to experience discomfort and side effects but no benefit from the sham device. This can make MAD appear more effective than it actually is. Comparing MAD to no treatment is important to ensure the benefits of MAD are not overestimated. The second question is important as there is a wide range of MADs available and it is not known which type is the most effective. The aim of this study is to evaluate the clinical effectiveness and costs in a 'real life' setting where participants may not necessarily follow the prescribed MAD treatment due to inconvenience, discomfort and other side effects.

Who can participate?
Patients aged over 18 with mild to moderate OSAH

What does the study involve?
This study compares three types of MAD:
1. Bespoke: custom made, professionally fitted
2. Semi-bespoke: commercially available postal kit where self-fit MADs are formed from a dental impression mould used by the patient
3. Over the counter: commercially available off the shelf kit where the patient 'boils and bites' thermoplastic MAD
All participants receive four treatments (bespoke, semi-bespoke, over the counter, no treatment) for a period of 6 weeks each, in a random order. The first two weeks of this are an 'acclimatisation phase' where the patient is given the opportunity to get used to the device, followed by a 4 week 'treatment phase' where we assess how well the treatment is working. Between each treatment period there is a 1 week 'wash out' interval to ensure that any effects of the last treatment have worn off before starting a new treatment. We measure how often the patients’ breathing is paused or reduced during sleep using a home portable measurement device in the final week of each treatment period. We also measure quality of life, patient symptoms and daily functioning at the end of each treatment period. Side effects experienced using each device, cost of treatment, number of withdrawals from the study and patient preference are also measured. Participants choose which device they prefer at the end of the study.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Papworth Hospital (UK)

When is the study starting and how long is it expected to run for?
September 2010 to June 2012

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)

Who is the main contact?
Dr Tim Quinnell

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centre

Sponsor information

Papworth Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

Papworth Everard
Cambridge
CB23 3RE
England
United Kingdom

Website	http://www.papworthhospital.nhs.uk/index.php
"ROR"	https://ror.org/01qbebb31

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

26/05/2016: Plain English summary added.