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Neck Grasp as a Predictor of Sleep Apnea

Primary Purpose

Obstructive Sleep Apnea, Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
polysomnogram
home sleep test
Easy Sleep Apnea Predictor
Sponsored by
Bassett Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bassett Healthcare Network

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Sleep Apnea assessment

Arm Description

all participants are in the same arm & undergo the same assessments: PSG, HST, ESAP

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

results of HST
Positive HST would indicate presence of OSA
Result of PSG testing
Positive PSG would indicate presence of OSA

Full Information

First Posted
June 9, 2015
Last Updated
January 16, 2017
Sponsor
Bassett Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT02474823
Brief Title
Neck Grasp as a Predictor of Sleep Apnea
Official Title
Neck Grasp as a Predictor of Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bassett Healthcare

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Type 2 Diabetes

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep Apnea assessment
Arm Type
Other
Arm Description
all participants are in the same arm & undergo the same assessments: PSG, HST, ESAP
Intervention Type
Other
Intervention Name(s)
polysomnogram
Other Intervention Name(s)
PSG
Intervention Description
all participants will undergo PSG for assessment of OSA
Intervention Type
Other
Intervention Name(s)
home sleep test
Other Intervention Name(s)
HST
Intervention Description
all participants will undergo HST for assessment of OSA
Intervention Type
Other
Intervention Name(s)
Easy Sleep Apnea Predictor
Other Intervention Name(s)
ESAP , self neck grasp
Intervention Description
all participants will undergo ESAP for assessment of OSA
Primary Outcome Measure Information:
Title
Result of ESAP testing
Description
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
Secondary Outcome Measure Information:
Title
results of HST
Description
Positive HST would indicate presence of OSA
Time Frame
3 months
Title
Result of PSG testing
Description
Positive PSG would indicate presence of OSA
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
lee edmonds, MD
Organizational Affiliation
Bassett Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bassett Healthcare Network
City
Cooperstown
State/Province
New York
ZIP/Postal Code
13326
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31355009
Citation
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.
Results Reference
derived

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Neck Grasp as a Predictor of Sleep Apnea

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