Clinical trial NCT04124978: Evaluation of Prefabricated Adjustable Thermoplastic Mandibular Advancement Devices for Obstructive Sleep Apnoea
Official title: Evaluation of the Effectiveness of Direct to Consumer Mandibular Advancement Devices as an Adjunct for the Treatment of Mild to Moderate Obstructive Sleep Apnoea (OSA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
mandibular advancement device
thermoplastic
adjustable
MyTAP
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2019-10-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Apnea-Hypopnea Index (AHI)
timeFrame: 3 months
measure: Apnea index (AI)
timeFrame: 3 months
measure: Hypopnea index (HI)
timeFrame: 3 months
measure: Oxygen disturbance index (ODI)
timeFrame: 3 months
measure: Lowest oxygen saturation (Lsat)
timeFrame: 3 months
measure: Epworth sleepiness score (ESS)
timeFrame: 3 months
measure: Abbreviated functional outcomes of sleep questionnaire (FOSQ-10)
timeFrame: 3 months
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: 3 months
Secondary outcomes:
measure: Predicting future use
timeFrame: 3 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Toh Song Tar, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.