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

Obstructive Sleep Apnea Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04124978
• Other study ID #: 2016/3100
• Status: Completed
• Phase: N/A
• Start date: July 21, 2017
• Est. completion date: April 23, 2019

Study information

• Verified date: October 2019
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 23, 2019
• Est. primary completion date: January 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• mandibular advancement device
use of prefabricated adjustable mandibular advancement device to improve OSA

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-Hypopnea Index (AHI)	apnea-hypopnea index	3 months
Primary	Apnea index (AI)	apnea index	3 months
Primary	Hypopnea index (HI)	Hypopnea index	3 months
Primary	Oxygen disturbance index (ODI)	Oxygen disturbance index	3 months
Primary	Lowest oxygen saturation (Lsat)	Lowest oxygen saturation	3 months
Primary	Epworth sleepiness score (ESS)	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.	3 months
Primary	Abbreviated functional outcomes of sleep questionnaire (FOSQ-10)	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.	3 months
Primary	Pittsburgh sleep quality index (PSQI)	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.	3 months
Secondary	Predicting future use	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.	3 months