Neck Grasp as a Predictor of Sleep Apnea
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | July 2015 |
| Contact: | jennifer victory, RN |
| Email: | jennifer.victory@bassett.org |
| Phone: | 607-547-6965 |
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.
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.
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.
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
We found this trial at
1
site
Cooperstown, New York 13326
Principal Investigator: lee edmonds, MD
Phone: 607-547-6965
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