Neck Grasp as a Predictor of Sleep Apnea

NCT02474823 | Completed

• 1 other identifier: 2012
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (2)

• results of HST

  3 months

• Result of PSG testing

  3 months

Study Arms (1)

Sleep Apnea assessment

OTHER

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

Interventions

polysomnogram OTHER

all participants will undergo PSG for assessment of OSA

Also known as: PSG

Sleep Apnea assessment

home sleep test OTHER

all participants will undergo HST for assessment of OSA

Also known as: HST

Sleep Apnea assessment

Easy Sleep Apnea Predictor OTHER

all participants will undergo ESAP for assessment of OSA

Also known as: ESAP , self neck grasp

Sleep Apnea assessment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old regardless of gender
• Confirmed diagnosis of Type 2 diabetes

You may not qualify if:

• 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

Sponsors & Collaborators

• Bassett Healthcare: lead

Study Sites (1)

Bassett Healthcare Network

Cooperstown, New York, 13326, United States

Location

Related Publications (1)

• 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.

  PMID: 31355009 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• lee edmonds, MD

  Bassett Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician - Pulmonology

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: June 18, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

US (1)