An interventional study of polysomnogram and home sleep test in Obstructive Sleep Apnea and Type 2 Diabetes, sponsored by Bassett Healthcare. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-01-18.
Sponsored by Bassett Healthcare · Not applicable, Interventional, and Diagnostic
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.
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 45 is close to the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Bassett Healthcare is the lead sponsor of 22 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
all participants are in the same arm \& undergo the same assessments: PSG, HST, ESAP
Other: polysomnogram · Other: home sleep test · Other: Easy Sleep Apnea Predictor
all participants will undergo PSG for assessment of OSA
Also known as: PSG
all participants will undergo HST for assessment of OSA
Also known as: HST
all participants will undergo ESAP for assessment of OSA
Also known as: ESAP , self neck grasp
Result of ESAP testing
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.
Time frame: 3 months
results of HST
Positive HST would indicate presence of OSA
Time frame: 3 months
Result of PSG testing
Positive PSG would indicate presence of OSA
Time frame: 3 months
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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