NCT02329925

Brief Summary

The coordination of swallowing and breathing is an important mechanism because the route for air and deglutition is partly shared in the pharynx. Tongue Stabilizing Device (TSD) is a preformed appliance for Obstructive Sleep Apnea (OSA) that protrudes the tongue and improves upper airway structure and function during sleep. Investigators will attempt to assess efficacy of TSD therapy on OSA and the physiological change of swallowing and breathing routes in OSA patients during sleep.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

December 12, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

4.3 years

First QC Date

December 12, 2014

Last Update Submit

November 24, 2022

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (4)

  • Apnea-hypopnea index

    Measuring apnea-hypopnea index (events/hour) to measure intervention efficacy (e.g. AHI)

    At baseline

  • Apnea-hypopnea index

    Measuring changes in apnea-hypopnea index (events/hour) to compare baseline and 2-6 months of TSD treatment follow up.

    At 2-6 months of TSD treatment follow up

  • Frequency of swallowing

    Measuring frequency of swallowing (events/hour) to assess influence by intervention

    At baseline

  • Frequency of swallowing

    Measuring changes in frequency of swallowing (events/hour) to compare baseline and 2-6 months of TSD treatment follow up.

    At 2-6 months of TSD treatment follow up

Secondary Outcomes (11)

  • Functional Outcomes of Sleep Questionnaire (FOSQ) responses

    At baseline

  • Functional Outcomes of Sleep Questionnaire (FOSQ) responses

    At 2-6 months of TSD treatment follow up

  • Epworth Sleepiness Scale (ESS) questionnaire responses.

    At baseline

  • Epworth Sleepiness Scale (ESS) questionnaire responses.

    At 2-6 months of TSD treatment follow up

  • VR-36 survey responses

    At baseline

  • +6 more secondary outcomes

Study Arms (1)

Tongue Stabilizing Device Treatment

EXPERIMENTAL

Tongue Stabilizing Device (TSD) is a preformed appliance for OSA that protrudes the tongue and improves upper airway structure and function during sleep.

Device: Tongue Stabilizing Device (TSD)

Interventions

Tongue Stabilizing Device (TSD)DEVICE

Tongue Stabilizing Device (TSD) is a preformed appliance for OSA that protrudes the tongue and improves upper airway structure and function during sleep.

Tongue Stabilizing Device Treatment

Eligibility Criteria

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

You may qualify if:

  • Patients included in this study must:
  • be 18 years of age or older
  • have an objective diagnosis of mild to moderate obstructive sleep apnea (OSA) \[5 ≤ AHI ≤ 50\]; and
  • have a Body Mass Index (BMI) ≤ 35

You may not qualify if:

  • Patients are excluded in this study who:
  • have had previous surgery of the soft palate;
  • have neuromuscular disease;
  • are taking medications which disturb sleep; and/or
  • have ≤ 90% oxygen saturation levels for 20% of the night.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

Location

Related Publications (1)

  • Alshhrani WM, Hamoda MM, Okuno K, Kohzuka Y, Fleetham JA, Ayas NT, Comey R, Almeida FR. The efficacy of a titrated tongue-stabilizing device on obstructive sleep apnea: a quasi-experimental study. J Clin Sleep Med. 2021 Aug 1;17(8):1607-1618. doi: 10.5664/jcsm.9260.

    PMID: 33745505DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Fernanda R Almeida, DDS, MSc, PhD

    University of British Columbia

    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
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

December 12, 2014

First Posted

January 1, 2015

Study Start

January 1, 2015

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

November 30, 2022

Record last verified: 2022-11

Locations

CA(1)