Can the mandibular advancement devices used for sleep apnoea reduce night time reflux?

Can mandibular advancement device treatment for obstructive sleep apnoea reduce nocturnal gastro-oesophageal reflux: a feasibility study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16013232

Enrollment

Registered

2022-10-13

Start date

2023-02-20

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive sleep apnoea and nocturnal gastro-oesophageal reflux Digestive System

Interventions

Visit 1 (Screening Visit) Medical history will be updated, and a full intraoral soft tissue and hard tissue examination will be completed. Participants will complete a reflux symptom index (RSI) quest

Itamar Medical Ltd., Caesarea, Israel), and given comprehensive instructions on how to perform a home sleep study. After their overnight sleep study with reflux monitoring, they will return the follo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 5, no frank cavitation or loose crowns/bridges) 6. Willing and able to provide informed consent to the study

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 13/06/2023: 1. Percentage of approached patients who were screened for the trial measured using the percentage of patients eligible of those screened at Day 2 of the screening visit. 2. Percentage of eligible patients who were randomised measured using the percentage of screened patients who met the eligibility criteria versus those who were randomised at the randomisation timepoint. 3. Percentage of patients who completed the trial measured using number of patients who were randomised versus those who completed the trial at Day 2 of the final visit. _____ Previous primary outcome measure: 1. Patient screening to recruitment ratio 2. Patient willingness to be randomised and retention in the study 3. Acceptability of the trial and interventions in terms of the burden placed on patients such as, two impedance monitoring tests, following the same diet on the day of the test and ability to wear the Watch-PAT device and the CPAP or a MAD at the same time.	—

Measure

Time frame

Current primary outcome measure as of 13/06/2023: 1. Percentage of approached patients who were screened for the trial measured using the percentage of patients eligible of those screened at Day 2 of the screening visit. 2. Percentage of eligible patients who were randomised measured using the percentage of screened patients who met the eligibility criteria versus those who were randomised at the randomisation timepoint. 3. Percentage of patients who completed the trial measured using number of patients who were randomised versus those who completed the trial at Day 2 of the final visit. _____ Previous primary outcome measure: 1. Patient screening to recruitment ratio 2. Patient willingness to be randomised and retention in the study 3. Acceptability of the trial and interventions in terms of the burden placed on patients such as, two impedance monitoring tests, following the same diet on the day of the test and ability to wear the Watch-PAT device and the CPAP or a MAD at the same time.

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Secondary

Measure	Time frame
Current secondary outcome measures as of 13/06/2023: 1. Patient acceptability of the trial measured using qualitative interviews throughout the trial. 2. Hours that device is worn during sleep measured using the average number of hours worn per night as detected from the output from the therapeutic device throughout the trial period. 3. To assess the most sensitive quality of life questionnaire prior to the full trial by recording EQ-5D-5L, ICE-CAP A, and SWEMWBS at baseline and post intervention. 4. Rating of both therapies measured using a Visual Analog Scale (VAS) at Day 2 of final assessment visit (trial completion). 5. Number of potential participants identified by the care team with and without screening of referral letters measured using number of participants identified on clinics before the prescreening clinic and after the pre-screening. 6. Change in Reflux Symptom Index (RSI) using changes detected in the RSI validated questionnaire at baseline and post intervention. 7. Change in Epworth Sleepiness Scale (ESS) using changes detected in the ESS validated questionnaire at baseline and post intervention. 8. Change in cough using changes detected in the validated Leicester Cough Questionnaire at baseline and post intervention. 9. To identify and measure indicative costs and outcomes and select suitable economic outcomes measured by documenting health resource use including intervention costs, appointment times and attending health care practitioners throughout the trial. 10. To determine the acceptability of the intervention and economic data collection methods measured using qualitative questions at the qualitative interview (various timepoints). _____ Previous secondary outcome measures: 1. To determine an estimate of effect size of the clinical effectiveness of MADs and CPAP therapy at reducing nocturnal gastro-oesophageal reflux will be assessed. This will be done both while the device is in situ to determine the effect of the device and over the ent	—

Measure

Time frame

Current secondary outcome measures as of 13/06/2023: 1. Patient acceptability of the trial measured using qualitative interviews throughout the trial. 2. Hours that device is worn during sleep measured using the average number of hours worn per night as detected from the output from the therapeutic device throughout the trial period. 3. To assess the most sensitive quality of life questionnaire prior to the full trial by recording EQ-5D-5L, ICE-CAP A, and SWEMWBS at baseline and post intervention. 4. Rating of both therapies measured using a Visual Analog Scale (VAS) at Day 2 of final assessment visit (trial completion). 5. Number of potential participants identified by the care team with and without screening of referral letters measured using number of participants identified on clinics before the prescreening clinic and after the pre-screening. 6. Change in Reflux Symptom Index (RSI) using changes detected in the RSI validated questionnaire at baseline and post intervention. 7. Change in Epworth Sleepiness Scale (ESS) using changes detected in the ESS validated questionnaire at baseline and post intervention. 8. Change in cough using changes detected in the validated Leicester Cough Questionnaire at baseline and post intervention. 9. To identify and measure indicative costs and outcomes and select suitable economic outcomes measured by documenting health resource use including intervention costs, appointment times and attending health care practitioners throughout the trial. 10. To determine the acceptability of the intervention and economic data collection methods measured using qualitative questions at the qualitative interview (various timepoints). _____ Previous secondary outcome measures: 1. To determine an estimate of effect size of the clinical effectiveness of MADs and CPAP therapy at reducing nocturnal gastro-oesophageal reflux will be assessed. This will be done both while the device is in situ to determine the effect of the device and over the ent

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 8, 2026