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

NCT ID: NCT04124978

Last Updated: 2019-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-21
• Study Completion Date: 2019-04-23

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

prospective, single armed, single centre trial study using the MyTAP device on a daily basis for a period of 3 months

Group Type: EXPERIMENTAL

mandibular advancement device

Intervention Type: DEVICE

use of prefabricated adjustable mandibular advancement device to improve OSA

Interventions

mandibular advancement device

use of prefabricated adjustable mandibular advancement device to improve OSA

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Singapore General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Toh Song Tar, MBBS

Role: PRINCIPAL_INVESTIGATOR

Singapore General Hospital

Locations

Singapore General Hospital

Singapore, , Singapore

Countries

Singapore

References

Soh L, Han HJ, Yue Y, Tay JY, Hao Y, Toh ST. Evaluation of prefabricated adjustable thermoplastic mandibular advancement devices (PAT-MADs) for obstructive sleep apnea: an Asian experience. Sleep Med. 2020 Nov;75:96-102. doi: 10.1016/j.sleep.2020.02.025. Epub 2020 Mar 7.

Reference Type: DERIVED

PMID: 32853924 (View on PubMed)

Other Identifiers

2016/3100

Identifier Type: -

Identifier Source: org_study_id