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
|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|
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)|
|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|
Sleep Apnea assessment
all participants are in the same arm & undergo the same assessments: PSG, HST, ESAP
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
- 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.
- results of HST [ Time Frame: 3 months ]Positive HST would indicate presence of OSA
- Result of PSG testing [ Time Frame: 3 months ]Positive PSG would indicate presence of OSA
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
|United States, New York|
|Bassett Healthcare Network|
|Cooperstown, New York, United States, 13326|
|Principal Investigator:||lee edmonds, MD||Bassett Healthcare|