Neck Grasp as a Predictor of Sleep Apnea

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02474823
Study type	Interventional
Source	Bassett Healthcare
Contact
Status	Completed
Phase	N/A
Start date	July 2015
Completion date	July 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05219994` - Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum	N/A
Completed	`NCT04056208` - Pistachios Blood Sugar Control, Heart and Gut Health	Phase 2
Completed	`NCT02284893` - Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone	Phase 3
Completed	`NCT04274660` - Evaluation of Diabetes and WELLbeing Programme	N/A
Active, not recruiting	`NCT05887817` - Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)	Phase 4
Active, not recruiting	`NCT05566847` - Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes	N/A
Recruiting	`NCT06007404` - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Completed	`NCT04965506` - A Study of IBI362 in Chinese Patients With Type 2 Diabetes	Phase 2
Recruiting	`NCT06115265` - Ketogenic Diet and Diabetes Demonstration Project	N/A
Active, not recruiting	`NCT03982381` - SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes	Phase 4
Completed	`NCT04971317` - The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages	N/A
Completed	`NCT04496154` - Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood	N/A
Completed	`NCT04023539` - Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes	N/A
Recruiting	`NCT05572814` - Transform: Teaching, Technology, and Teams	N/A
Enrolling by invitation	`NCT05530356` - Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
Completed	`NCT04097600` - A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets	Phase 1
Completed	`NCT03960424` - Diabetes Management Program for Hispanic/Latino	N/A
Completed	`NCT05378282` - Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics
Active, not recruiting	`NCT06010004` - A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes	Phase 3
Completed	`NCT03653091` - Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes	N/A