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Neck Grasp as a Predictor of Sleep Apnea

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ClinicalTrials.gov Identifier: NCT02474823
Recruitment Status : Completed
First Posted : June 18, 2015
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Lee Edmonds, MD, Bassett Healthcare

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Type 2 Diabetes Other: polysomnogram Other: home sleep test Other: Easy Sleep Apnea Predictor Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Neck Grasp as a Predictor of Sleep Apnea
Study Start Date : July 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Sleep Apnea assessment
all participants are in the same arm & undergo the same assessments: PSG, HST, ESAP
Other: polysomnogram
all participants will undergo PSG for assessment of OSA
Other Name: PSG

Other: home sleep test
all participants will undergo HST for assessment of OSA
Other Name: HST

Other: Easy Sleep Apnea Predictor
all participants will undergo ESAP for assessment of OSA
Other Name: ESAP , self neck grasp




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02474823


Locations
United States, New York
Bassett Healthcare Network
Cooperstown, New York, United States, 13326
Sponsors and Collaborators
Bassett Healthcare
Investigators
Principal Investigator: lee edmonds, MD Bassett Healthcare

Responsible Party: Lee Edmonds, MD, attending physician - Pulmonology, Bassett Healthcare
ClinicalTrials.gov Identifier: NCT02474823     History of Changes
Other Study ID Numbers: 2012
First Posted: June 18, 2015    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 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