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ArticleTrials2021

Intervention to enhance adherence to mandibular advancement appliance in patients with obstructive sleep apnoea: study protocol for a randomised clinical trial.

Harishri Tallamraju, J Tim Newton, Padhraig S Fleming, Ama Johal

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04092660 (Intervention to Enhance Adherence to Mandibular Advancement Appliance in Patients With Obstructive Sleep Apnoea), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.1field-weighted citation impact, top 52% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04092660 narecruitingnot on this map

Intervention to Enhance Adherence to Mandibular Advancement Appliance in Patients With Obstructive Sleep Apnoea: A Randomized Control Trial

TypeinterventionalSponsorQueen Mary University of LondonRan2019 to 2026Enrolled56ConditionsObstructive Sleep ApneaArmsBehaviour change Intervention Based on Health Action Process Approach Model, Mandibular Advancement Appliance (MAA) or Anti-snoring mouth guard
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 1 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

Harishri TallamrajuCentre of Oral Bioengineering, Institute of Dentistry, Queen Mary University of London, Turner Street, London, E1 2AD, UK. h.tallamraju@qmul.ac.uk.ORCID http://orcid.org/0000-0003-0648-300X
J Tim NewtonDepartment of Population and Patient Health, Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London, London, UK.
Padhraig S FlemingCentre of Oral Bioengineering, Institute of Dentistry, Queen Mary University of London, Turner Street, London, E1 2AD, UK.
Ama JohalCentre of Oral Bioengineering, Institute of Dentistry, Queen Mary University of London, Turner Street, London, E1 2AD, UK.
Queen Mary University of London · GBKing's College London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundObstructive sleep apnoea (OSA) is a sleep-related breathing disorder characterised by the repeated episodic collapse of the upper airway during sleep, resulting in sleep deprivation, giving rise to apnoeas and hypopnoeas. Based on the severity of OSA, there are two primary treatment modalities, continuous positive airway pressure (CPAP) and mandibular advancement appliances (MAA); both are adherence-dependent. MAA is offered to those with mild to moderate OSA and is prescribed as an alternative to patients intolerable to CPAP. However, adherence to MAA treatment is variable and declines over time. Hence, the current study aims to assess the effectiveness of the stage-matched intervention, the Health Action Process Approach (HAPA), on adherence to MAA in patients with OSA.

methodsA single-centre randomised clinical trial will be undertaken at Bart's Health NHS Trust. Fifty-six participants with newly diagnosed OSA are planned to be enrolled in the study and randomised to intervention care (IC) and standardised care (SC) groups. Participants in the SC group will receive routine care whilst participants in the IC group will receive the stage-matched intervention, developed using the HAPA model. Data indicating MAA adherence will be collected both objectively and subjectively, from micro-sensors embedded in the MAA design and sleep diaries, respectively at 3, 6, 18 and 36 months. In addition, a range of questionnaires designed to assess risk perception, outcome expectancy, and self-efficacy (SEMSA) and quality of sleep (PSQI and ESS) and life (EQ-5DL), socio-economic and social support scales will be used. DISCUSSION: The currently available treatments for obstructive sleep apnoea depend entirely on the patient's acceptance and use. There are several factors that affect cooperation and wear for example patients' awareness of their condition, social support and psychological behaviour. In addition, mood, such as anxiety, stress, and depression, may affect wear. At the same time, we know that interventions involving more education and behaviour approaches can help patients adapt more easily to some treatments. As a result, the present trial aims to explore the potential role of these factors to maximise treatment success and minimise side effects.

trial registrationClinicalTrials.gov NCT04092660 . Registered on September 6, 2019.

Indexed as

Mandibular AdvancementSleep Apnea, ObstructiveContinuous Positive Airway PressureHumansRandomized Controlled Trials as TopicSleepSurveys and QuestionnairesTreatment OutcomeHealth Action Process ApproachMandibular advancement applianceObstructive sleep apnoeaPatient adherenceStaged-matched intervention

Identifiers

PMID34645490
PMCPMC8511865
OpenAlexW3207050963

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.