Quantitative Genioglossal Muscle Strength in Obstructive Sleep Apnea (OSAS)

NCT ID: NCT02695667

Last Updated: 2024-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-03-31

Brief Summary

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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

Detailed Description

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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."

Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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OSAS subjects

CPAP Referral OSAS

No interventions assigned to this group

Risk-Free subjects

paired normal control subjects

No interventions assigned to this group

Eligibility Criteria

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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

\-
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip Eaton, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

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Clinical Translational Science Center

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Other Identifiers

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15-120

Identifier Type: -

Identifier Source: org_study_id

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