Quantitative Genioglossal Muscle Strength in Obstructive Sleep Apnea (OSAS) (EatonOSAS)

January 4, 2024 updated by: University of New Mexico

Quantitative Genioglossal Muscle Strength in Obstructive Sleep Apnea (OSAS) Defined in the Clinical Spectrum of Subjects With Snoring Disturbance, Oral Appliance Therapy Responsive, and CPAP Responsive.

Quantitative Genioglossal muscle strength in Obstructive Sleep Apnea (OSAS) defined in the clinical spectrum of subjects with Snoring Disturbance, Oral Appliance Therapy Responsive, and CPAP Responsive

Study Overview

Status

Terminated

Conditions

Detailed Description

To describe by statistical analysis the normal distribution domain of genioglossus muscle strength in each of the four clinical stages of Sleep Apnea; and, by regression analysis, to explore the possibility of an inverse relationship between decreasing genioglossus strength and progression of the clinical stages of OSAS.

1.3. To test the hypothesis that a "subpopulation of subject" exists within the clinical spectrum of OSAS, in whom decreasing strength of the genioglossus muscle may represent a common element in spite of differing possible pathophysiologic pathways leading to Obstructive Sleep Apnea in man. 1.4. The major hypothesis of this proposal is thus that "Genioglossal Strength is inversely correlated with Obstructive Sleep Apnea Pathology."

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Clinical Translational Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

This initial pilot investigation will screen up to 70 individuals to obtain the necessary enrollment of 22 subjects per group from Stage Three: CPAP Referral OSAS; and paired normal control subjects

Description

Inclusion Criteria:

  • Age 20-40 years inclusive BMI 18-25 Non-smoking history and no current use for a minimum of 6 months No smokeless tobacco products (including e-cigarettes) for a minimum of 6 months No sleep snoring reported by subject and by bedroom "companion" Self-described as active/athletic (i.e. regular hikes, walks, jogging, running, active Sports, such as volleyball, soccer, etc.) Self-described as healthy, with no known disease or recent illness Self-completed Epworth Sleepiness Scale of <6 (Johns, MW, A new method for Measuring daytime sleepiness: the Epworth Sleepiness Scale; SLEEP 14:450-5, 1991). Physical Examination Mallampati Score of Class 1 (Nuckton, TJ, et al: Physical

Examination: Mallampati Score as an Independent Predictor of OSAS; SLEEP 29:

903-908, 2006).

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
OSAS subjects
CPAP Referral OSAS
Risk-Free subjects
paired normal control subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genioglossal Strength
Time Frame: single clinic visit
quantitative measurement of tongue strength
single clinic visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Investigators

  • Principal Investigator: Philip Eaton, MD, University of New Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

February 24, 2016

First Submitted That Met QC Criteria

February 29, 2016

First Posted (Estimated)

March 1, 2016

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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