Evaluation of Prefabricated Adjustable Thermoplastic Mandibular Advancement Devices for Obstructive Sleep Apnoea

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: mandibular advancement device

• Registration Number: NCT04124978
• Lead Sponsor: Singapore General Hospital

Brief Summary

Use of mandibular advancement devices(MADs) in the treatment of Obstructive Sleep Apnea is established, however this is hampered by high costs, long wait times and non-assured success in the local Asian setting. There are few studies which look at the use of prefabricated thermoplastic mandibular devices with a titratable component and its efficacy. In addition, it is direct-to-consumer and an economical option, thus there may be a role in the use of such devices to better select patients who may benefit and are thinking of using MADs.

The investigators aim to evaluate the effectiveness of the use of Prefabricated adjustable thermoplastic mandibular advancement devices(PAT-MADs)(MyTAP) in the treatment of OSA and its role for predicting treatment success in an Asian population.

Detailed Description

Mandibular advancement devices (MAD) serve as an adjunct to the treatment of snoring as well as mild-moderate OSA. It is widely accepted that upper airway muscle activity decreases during sleep, leading to increased collapsibility of the pharyngeal tissues, mandibular opening and posterior displacement of the tongue. These changes result in narrowing of the oropharyngeal and hypopharyngeal airway (Hudgel 1992). Their primary action is to advance the mandible and tongue to increase the upper airway size. Recent systemic review on the effectiveness of MAD in treating OSA by Torres et al in the Laryngoscope showed that 16 out of 18 large scale studies showed significant improvement in Apnea-Hypopnea index (AHI).

There are a wide variety of MAD commercially available and they can be broadly divided into custom made vs prefabricated makes as well as titratable versus non-titratable types. It is shown that custom made, titratable fitted MADs are superior in efficacy as compared to their counterpart models. However, high cost, delayed waiting times and multiple clinic visits are required for patients to be fitted with custom MADs by a professional orthodontist. Newly developed direct to consumer thermoplastic MADs (MyTap) brings the benefit of mouldable bite and form "custom" fit with the option of titration to the user at a lower cost, technical ease of use and fit in the clinic setting.

Participants who are diagnosed with simple snoring or mild to moderate OSA are able to trial use thermoplastic MADs to have a sense of the level of comfort and effectiveness MAD can bring to improve their OSA, serving as a bridging device prior to committing to the use of custom made MAD.

The investigators aim to evaluate the effectiveness of the use of Prefabricated adjustable thermoplastic mandibular advancement devices(PAT-MADs)(MyTAP) in the treatment of OSA and its role for predicting treatment success, compliance and comfort in an Asian population.

Study Timeline

• Study Start: 2017-07-21
• Primary Completion: 2019-01-23
• Study Completion: 2019-04-23
• Status Verified: 2019-10
• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-10
• Last Update Submitted: 2019-10-13
• Study First Posted: 2019-10-14
• Last Update Posted: 2019-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• 18years old and above
• English competency
• Formal diagnosis of mild-moderate OSA on PSG
• Ability to provide informed consent

Exclusion Criteria

• diagnosed severe OSA
• evidence of central sleep apnea events
• dental conditions which preclude proper use of the MAD
• treatment with other devices (e.g. tongue retainers, PAP therapy)
• pregnancy
• known allergic reactions to the components of the study product were excluded from the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	mandibular advancement device	prospective, single armed, single centre trial study using the MyTAP device on a daily basis for a period of 3 months

Primary Outcome Measures

Name	Time	Method
Epworth sleepiness score (ESS)	3 months	Epworth sleepiness score measures the level of sleepiness in a participant. Minimum value of 0 to a maximum level of 24, whereby the higher the value, the sleepier the participant.
Pittsburgh sleep quality index (PSQI)	3 months	Quality of life survey made up of 19 self rated questions which assesses the quality of 7 different aspects of sleep in participants with sleep disorders. Minimum value is 0 and maximum value is 21, where the higher the global value, the more severe the difficulties in different aspects of sleep.
Apnea-Hypopnea Index (AHI)	3 months	apnea-hypopnea index
Oxygen disturbance index (ODI)	3 months	Oxygen disturbance index
Lowest oxygen saturation (Lsat)	3 months	Lowest oxygen saturation
Apnea index (AI)	3 months	apnea index
Hypopnea index (HI)	3 months	Hypopnea index
Abbreviated functional outcomes of sleep questionnaire (FOSQ-10)	3 months	Quality of life survey made of up 10 self rated questions which assess the quality of sleep in participants with sleep disorders. Minimum value is 0 and maximum value is 40, where the lower the global value, the worse off the quality of sleep.

Secondary Outcome Measures

Name	Time	Method
Predicting future use	3 months	if the use of PAT-MAD is an acceptable treatment to patients who are keen to try customizable MAD but are unsure of the treatment suitability and effectiveness for their OSA, in the form of adherence, self/3rd party reported symptom improvement and ease of use.

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore