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The Efficacy of Tongue Stabilizing Device in Patients With Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT02329925
Recruitment Status : Active, not recruiting
First Posted : January 1, 2015
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Fernanda Almeida, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Tongue Stabilizing Device (TSD) Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Tongue Stabilizing Device in Patients With Obstructive Sleep Apnea
Actual Study Start Date : January 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Tongue Stabilizing Device Treatment
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)
Tongue Stabilizing Device (TSD) is a preformed appliance for OSA that protrudes the tongue and improves upper airway structure and function during sleep.




Primary Outcome Measures :
  1. Apnea-hypopnea index [ Time Frame: At baseline ]
    Measuring apnea-hypopnea index (events/hour) to measure intervention efficacy (e.g. AHI)

  2. Apnea-hypopnea index [ Time Frame: At 2-6 months of TSD treatment follow up ]
    Measuring changes in apnea-hypopnea index (events/hour) to compare baseline and 2-6 months of TSD treatment follow up.

  3. Frequency of swallowing [ Time Frame: At baseline ]
    Measuring frequency of swallowing (events/hour) to assess influence by intervention

  4. Frequency of swallowing [ Time Frame: At 2-6 months of TSD treatment follow up ]
    Measuring changes in frequency of swallowing (events/hour) to compare baseline and 2-6 months of TSD treatment follow up.


Secondary Outcome Measures :
  1. Functional Outcomes of Sleep Questionnaire (FOSQ) responses [ Time Frame: At baseline ]
    Measuring Functional Outcomes of Sleep Questionnaire (FOSQ) responses to evaluate disease specific quality of life.

  2. Functional Outcomes of Sleep Questionnaire (FOSQ) responses [ Time Frame: At 2-6 months of TSD treatment follow up ]
    Measuring changes in Functional Outcomes of Sleep Questionnaire (FOSQ) responses to compare baseline and 2-6 months of TSD treatment follow up

  3. Epworth Sleepiness Scale (ESS) questionnaire responses. [ Time Frame: At baseline ]
    Measuring responses to Epworth Sleepiness Scale (ESS) Questionnaire to assess daytime sleepiness.

  4. Epworth Sleepiness Scale (ESS) questionnaire responses. [ Time Frame: At 2-6 months of TSD treatment follow up ]
    Measuring changes in responses to Epworth Sleepiness Scale (ESS) Questionnaire to compare baseline and 2-6 months of TSD treatment follow up

  5. VR-36 survey responses [ Time Frame: At baseline ]
    Measuring VR-36 survey responses which assesses general health status.

  6. VR-36 survey responses [ Time Frame: At 2-6 months of TSD treatment follow up ]
    Measuring changes in VR-36 survey responses to compare baseline and 2-6 months of TSD treatment follow up

  7. Breathing route [ Time Frame: At baseline ]
    Measuring breathing route to assess influence by intervention

  8. Breathing route [ Time Frame: At 2-6 months of TSD treatment follow up ]
    Measuring changes in breathing route to compare baseline and 2-6 months of TSD treatment follow up

  9. Swallowing apnea time [ Time Frame: At baseline ]
    Measuring swallowing apnea time (sec) to assess influence by intervention

  10. Swallowing apnea time [ Time Frame: At 2-6 months of TSD treatment follow up ]
    Measuring changes in swallowing apnea time (sec) to compare baseline and 2-6 months of TSD treatment follow up

  11. Compliance (Measuring adherence (hours/nights and nights/week of intervention use)) [ Time Frame: At 2-6 months of TSD treatment follow up ]
    Measuring adherence (hours/nights and nights/week of intervention use)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329925


Locations
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V6T 1Z3
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Fernanda R Almeida, DDS, MSc, PhD University of British Columbia

Responsible Party: Fernanda Almeida, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02329925     History of Changes
Other Study ID Numbers: H14-01333
First Posted: January 1, 2015    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases