Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2015-07-31
2016-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Sleep Apnea assessment
all participants are in the same arm \& undergo the same assessments: PSG, HST, ESAP
polysomnogram
all participants will undergo PSG for assessment of OSA
home sleep test
all participants will undergo HST for assessment of OSA
Easy Sleep Apnea Predictor
all participants will undergo ESAP for assessment of OSA
Interventions
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polysomnogram
all participants will undergo PSG for assessment of OSA
home sleep test
all participants will undergo HST for assessment of OSA
Easy Sleep Apnea Predictor
all participants will undergo ESAP for assessment of OSA
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of Type 2 diabetes
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Bassett Healthcare
OTHER
Responsible Party
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Lee Edmonds, MD
attending physician - Pulmonology
Principal Investigators
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lee edmonds, MD
Role: PRINCIPAL_INVESTIGATOR
Bassett Healthcare
Locations
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Bassett Healthcare Network
Cooperstown, New York, United States
Countries
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References
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Edmonds PJ, Gunasekaran K, Edmonds LC. Neck Grasp Predicts Obstructive Sleep Apnea in Type 2 Diabetes Mellitus. Sleep Disord. 2019 Jul 1;2019:3184382. doi: 10.1155/2019/3184382. eCollection 2019.
Other Identifiers
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2012
Identifier Type: -
Identifier Source: org_study_id
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