Quantitative Genioglossal Muscle Strength in Obstructive Sleep Apnea (OSAS)

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.

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02695667

Acronym

EatonOSAS

Enrollment

Registered

2016-03-01

Start date

2016-02-29

Completion date

2017-03-31

Last updated

2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

20 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Genioglossal Strength	single clinic visit	quantitative measurement of tongue strength

Countries

United States

Outcome results