Mandibular advancement device plus continuous positive airway pressure: does combining two established treatments for obstructive sleep apnoea give added benefits?

Positive Airway Pressure plus Mandibular Advancement Therapy (PAPMAT)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN33966032

Enrollment

Registered

2022-02-18

Start date

2022-05-01

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

Obstructive sleep apnoea Nervous System Diseases Sleep apnoea

Interventions

Recruitment: Patients attending a clinical appointment for initiation of CPAP who meet the inclusion criteria will be approached during their appointment. A member of the research team will explain th

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 01/05/2024: 1. Adults with moderate to severe OSAS defined by a 4% oxygen desaturation index (4% ODI) or apnoea hypopnoea index (AHI) =15/hour 2. An Epworth Sleepiness Scale (ESS) Score >10 3. Auto-titrated CPAP pressure of =12 cm water Previous inclusion criteria: 1. Adults with moderate to severe OSAS defined by a 4% oxygen desaturation index (4% ODI) or apnoea hypopnoea index (AHI) =15/hour 2. An Epworth Sleepiness Scale (ESS) Score >10 3. Auto-titrated CPAP pressure of =14 cm water

Exclusion criteria

Exclusion criteria: 1. Inadequate dentition or other contraindication to MAD determined by a clinician or trained CPAP provider 2. Co-morbid sleep disorder that might affect the patient’s ability to comply with treatment or benefit from therapy, or confound the interpretation of results 3. Unstable cardio-respiratory disease or other disorder/factor judged by the clinician to preclude trial participation due to safety concerns or significant potential to confound interpretation of results 4. Previous MAD or CPAP use 5. Other reason for an inability to comply with the trial protocol

Design outcomes

Primary

Measure	Time frame
CPAP adherence (means hours of use per night) measured using data downloaded from CPAP device after 10 weeks of treatment	—

Secondary

Measure	Time frame
1. CPAP pressure measured using CPAP data download after 10 weeks 2. Control of obstructive sleep apnoea (OSA) using a peripheral arterial tonometry (PAT) oximeter sleep monitor to determine the apnoea hypopnoea index (AHI) and 4% oxygen desaturation index (4% ODI) in each arm after 10 weeks 3. Diastolic and systolic blood pressure arms measured using office-based automated measurement with patient sitting after 10 weeks 4. Patient-reported outcomes measured after 10 weeks: 4.1. Subjective daytime sleepiness measured using the Epworth Sleepiness Scale 4.2. Quality of life measured using Functional Outcomes of Sleep Questionnaire (FOSQ), EuroQoL, Pittsburgh Sleep Quality Index (PSQI) 4.3. Patient satisfaction measured using visual analogue score	—

Measure

Time frame

1. CPAP pressure measured using CPAP data download after 10 weeks 2. Control of obstructive sleep apnoea (OSA) using a peripheral arterial tonometry (PAT) oximeter sleep monitor to determine the apnoea hypopnoea index (AHI) and 4% oxygen desaturation index (4% ODI) in each arm after 10 weeks 3. Diastolic and systolic blood pressure arms measured using office-based automated measurement with patient sitting after 10 weeks 4. Patient-reported outcomes measured after 10 weeks: 4.1. Subjective daytime sleepiness measured using the Epworth Sleepiness Scale 4.2. Quality of life measured using Functional Outcomes of Sleep Questionnaire (FOSQ), EuroQoL, Pittsburgh Sleep Quality Index (PSQI) 4.3. Patient satisfaction measured using visual analogue score

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 10, 2026