Obstructive sleep apnoea Nervous System Diseases Sleep disorders
Conditions
Interventions
The study will compare the clinical effectiveness and costs of three types of MAD (bespoke, semi-bespoke and over the counter) and a no treatment control for participants with mild to moderate OSAH. E
Sponsors
Papworth Hospital NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged greater than or equal to 18 years, either sex 2. Obstructive sleep apnoea-hypopnoea confirmed by respiratory polysomnogram with apnoea-hypopnoea index (AHI) 5 to 30/hours 3. Excessive daytime sleepiness (ESS) greater than or equal to 11 and/or participant reported sleepiness 4. Sufficient teeth to allow satisfactory device retention 5. Ability to give written informed consent
Exclusion criteria
Exclusion criteria: 1. Primary central sleep apnoea 2. Coexistent sleep disorder or drug treatment considered likely to have significant impact on symptoms (especially sleepiness) or MAD effectiveness 3. Severe and/or unstable cardiovascular disease judged by clinician to warrant immediate continuous positive airway pressure (CPAP) 4. Other medical or psychiatric disorder judged likely to adversely interact with MAD or confound interpretation of its effectiveness 5. Significant periodontal disease or tooth decay; partial or complete edentulism; presence of fixed orthodontic devices 6. Temporomandibular joint pain or disease 7. Severe bruxism 8. Restriction in mouth opening or advancement of mandible 9. Respiratory failure 10. Inability to give informed consent or comply with the protocol 11. Pregnant women 12. Any other significant clinical contra-indication, e.g. disabling sleepiness upgrading the obstructive sleep apnoea-hypopnoea (OSAH) to severe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apnoea-Hypopnoea Index (AHI). AHI is the frequency of apnoeas and hypopneas per hour of study. Measured at baseline and then in the final week of each treatment period (5 times in total). The sleep diary will be completed daily during the treatment periods. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Epworth Sleepiness Scale (ESS) 2. Physiological indices from the respiratory polysomngraphy (PSG) - 4% Oxygen Desaturation Index, mean, minimum and time less than 90% of nocturnal SpO2 3. Blood pressure 4. Functional status (Functional Outcome of Sleep Questionnaire [FOSQ]) 5. Generic (36-item short form health survey [SF-36]) and disease specific (Calgary Sleep Apnoea Quality of Life Index [SAQLI]) health related quality of life (HRQoL) 6. EuroQol EQ-5D transformed to the utility scale 7. Daily sleep diary (assessing adherence, hours use and retention) 8. Snoring scale (partner rated visual analogue scale) 9. Side effects, withdrawals and participant satisfaction and preference Measured at baseline and then in the final week of each treatment period (5 times in total). The sleep diary will be completed daily during the treatment periods. | — |
Countries
United Kingdom
Outcome results
None listed