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NCT Number: NCT02474823

Neck Grasp as a Predictor of Sleep Apnea

A previous pilot study on the use of self neck grasp, ESAP (Easy Sleep Apnea Predictor), showed a positive maneuver (unable to wrap hands completely around neck) to be 100% predictive of sleep apnea in a sleep clinic population. The investigators now would like to compare ESAP to other tests used to diagnose and screen for Sleep Apnea in type 2 diabetics. The tests will included Home Sleep Testing, sleep questionnaires Berlin and STOP-BANG and polysomnogram (PSG). Patients with type 2 diabetes in the Bassett Endocrine Clinic who are scheduled for a routine evaluation will be recruited to undergo; a Home Sleep Test along with two sleep questionnaires PSG. The screen test wil be compared to the results of the gold standard diagnostic test the PSG for their predictive value os OSA in the type 2 diabetic population.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Diabetes Mellitus Diabetes Mellitus, Type 2 Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Type 2 Diabetes

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bassett Healthcare Network

Cooperstown, New York, 13326, United States

About this study

The goal is to evaluate the ESAP study (simple neck grasp) as a predictor of Obstructive Sleep Apnea (OSA) in combination with, and in comparison to; Home Sleep Test ( HST), Berlin Sleep Questionnaire and STOP-BANG questionnaire. All predictors are being evaluated against the gold standard test, the polysomnogram (PSG).

OSA is the common disorder affecting 3-7% of the adult population. It has many negative health consequences such as; cardiovascular disease, diabetes, motor vehicle accidents and depression. Data from both epidemiological and clinical studies suggest that OSA is also independently associated with alterations in glucose metabolism and places patients at an increased risk of the development of type 2 diabetes It is often missed in a busy practice. This simple diagnostic tool may help us in identifying the patient at an earlier stage, thus also helping to prevent further complications in diabetic patients.

Participants will undergo 3 study visits/procedures:

Visit 1: Participants will be consented for the study, undergo the ESAP test, complete the Berlin Sleep Questionnaire & STOP-BANG questionnaire, and provide medical history/demographic information.

Visit 2: Participants will undergo a PSG at the Bassett Sleep Lab.. Visit 3: The morning the PSG is completed, participants will be given the HST recorder and instructed in its use in order to complete the HST. Participants can then drop off the HST recorder at any Bassett Clinic and it will be returned to the Sleep Lab in Cooperstown.

The ESAP test, Berlin Sleep Questionnaire, and the STOP-BANG Questionnaire will be administered by a study coordinator, research nurse, and/or research assistant. The PSG and the HST will be read and evaluated by independent evaluators/physicians. These physicians will not have access to the ESAP or the questionnaire results prior to the evaluation of the PSG or HST.

If a participant has any test (except the ESAP test alone) that is indicative or suspicious for OSA, a study physician will review these results and advise them of any further follow up recommendations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 - 70 years old regardless of gender
  • Confirmed diagnosis of Type 2 diabetes

Exclusion criteria

  • Unstable Heart failure
  • COPD
  • Neuromuscular disease
  • Mental disorders which would interfere with following directions
  • Persons who are already diagnosed with OSA or persons who have been using CPAP or BiPAP

Treatment and study plan

polysomnogram

Other

all participants will undergo PSG for assessment of OSA

Other names: PSG

home sleep test

Other

all participants will undergo HST for assessment of OSA

Other names: HST

Easy Sleep Apnea Predictor

Other

all participants will undergo ESAP for assessment of OSA

Other names: ESAP , self neck grasp

Primary outcomes

  1. Result of ESAP testing

    Time frame: 3 months

    The ESAP measures a participant's ability to wrap their own hands around their neck, touching thumb to thumb, middle finger to middle finger. A "positive" test (unable to reach around the neck with fingers) would be indicative of the presence of OSA.

Secondary outcomes

  1. results of HST

    Time frame: 3 months

    Positive HST would indicate presence of OSA

  2. Result of PSG testing

    Time frame: 3 months

    Positive PSG would indicate presence of OSA

Sponsors and collaborators

Lead sponsor

Bassett Healthcare

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 18, 2015
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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