NCT04124978

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
Last Updated

October 16, 2019

Status Verified

October 1, 2019

Enrollment Period

1.5 years

First QC Date

October 10, 2019

Last Update Submit

October 13, 2019

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apneamandibular advancement devicethermoplasticadjustableMyTAP

Outcome Measures

Primary Outcomes (8)

  • Apnea-Hypopnea Index (AHI)

    apnea-hypopnea index

    3 months

  • Apnea index (AI)

    apnea index

    3 months

  • Hypopnea index (HI)

    Hypopnea index

    3 months

  • Oxygen disturbance index (ODI)

    Oxygen disturbance index

    3 months

  • Lowest oxygen saturation (Lsat)

    Lowest oxygen saturation

    3 months

  • 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

  • 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

  • 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 Outcomes (1)

  • Predicting future use

    3 months

Study Arms (1)

Intervention group

EXPERIMENTAL

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

Device: mandibular advancement device

Interventions

mandibular advancement deviceDEVICE

use of prefabricated adjustable mandibular advancement device to improve OSA

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (1)

  • 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.

    PMID: 32853924DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Officials

  • Toh Song Tar, MBBS

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2019

First Posted

October 14, 2019

Study Start

July 21, 2017

Primary Completion

January 23, 2019

Study Completion

April 23, 2019

Last Updated

October 16, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)