Oral mandibular advancement devices for obstructive sleep apnoea-hypopnoea

Not Applicable

Completed

• Conditions: Nervous System Diseases; Obstructive sleep apnoea; Sleep disorders

• Registration Number: ISRCTN02309506
• Lead Sponsor: Papworth Hospital NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-18
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Apnoea-Hypopnoea Index (AHI). AHI is the frequency of apnoeas and hypopneas per hour of study. <br><br>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 Outcome Measures

Name	Time	Method
1. Epworth Sleepiness Scale (ESS)<br>2. Physiological indices from the respiratory polysomngraphy (PSG) - 4% Oxygen Desaturation Index, mean, minimum and time less than 90% of nocturnal SpO2<br>3. Blood pressure<br>4. Functional status (Functional Outcome of Sleep Questionnaire [FOSQ])<br>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)<br>6. EuroQol EQ-5D transformed to the utility scale<br>7. Daily sleep diary (assessing adherence, hours use and retention)<br>8. Snoring scale (partner rated visual analogue scale)<br>9. Side effects, withdrawals and participant satisfaction and preference<br><br>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.