Can the mandibular advancement devices used for sleep apnoea reduce night time reflux?
- Conditions
- Obstructive sleep apnoea and nocturnal gastro-oesophageal refluxDigestive System
- Registration Number
- ISRCTN16013232
- Lead Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Brief Summary
2023 Protocol article in https://doi.org/10.1136/bmjopen-2023-076661 (added 25/08/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 44
1. Adult patients aged 18 years old and over
2. Confirmed OSA with Apnoea-Hypopnoea Index (AHI) score between 10 and 30
3. Confirmed gastro-oesophageal reflux disease with greater than 6 percent of acid exposure time < pH 4 over 24 hours
4. Patient will not have previously had CPAP or MAD therapy
5. Sufficient healthy teeth to support a mandibular advancement device (10 teeth in each jaw, no periodontal pockets > 5, no frank cavitation or loose crowns/bridges)
6. Willing and able to provide informed consent to the study
1. Pregnancy or breast feeding
2. Unable or unwilling to stop GORD medication 2 days prior to assessment or unable to undergo manometry and pH impedence testing
3. Known liver disease or oesophageal/gastric varices
4. Previous surgery or intervention for reflux such as fundoplication
5. Any previous treatment for oesophageal neoplasia.
6. Unable/unwilling to tolerate either a CPAP mask or a mandibular advancement device
7. Medical history likely to impact on attendance or 24-hour impedance testing
8. Participation in other research within previous 30 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
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