Neck Grasp as a Predictor of Sleep Apnea
Condition: Obstructive Sleep Apnea; Type 2 Diabetes
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

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.
    

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.
    

Intervention name(s): polysomnogram; home sleep test; Easy Sleep Apnea Predictor
Intervention type(s): Other; Other; Other
Intervention description(s): all participants will undergo PSG for assessment of OSA; all participants will undergo HST for assessment of OSA; all participants will undergo ESAP for assessment of OSA
Other intervention name(s): PSG; HST; ESAP , self neck grasp
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic