Effect of Upper Airway Stimulation on Vascular Function in Obstructive Sleep Apnea

NCT03051165 | Terminated Results FDA Device

• 1 other identifier: IRB00088693
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effect of hypoglossal nerve stimulation (HGNS) on different measures of cardiovascular function in patients with obstructive sleep apnea (OSA). People with OSA who have undergone implantation of the hypoglossal nerve stimulator at the study site will be told about the study at their 2-week post-operative appointment. Those who decide to participate will have blood drawn and vascular function measurements taken before HGNS activation, during treatment, and after a temporary treatment withdrawal period. Following the 30-day period of treatment withdrawal, the HGNS therapy will be reactivated.

Conditions

Obstructive Sleep Apnea

Keywords

Cardiovascular Disease; Pulmonary Medicine; Hypoglossal Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

• Change in Peripheral Arterial Tonometry (PAT)

  Peripheral arterial tonometry (PAT) is a method for measuring endothelial dysfunction in a non-invasive way. Blood flow is measured in the fingertips following compression with an inflatable cuff on the upper arm. Participants will lay on their backs with a probe placed on the finger of each hand. The probes are attached to a computer that records finger blood flow. The finger probes will continuously record the blood flow in the fingertips for 10 minutes

  Baseline, Day 105, Day 137

Secondary Outcomes (8)

• Change in Flow Mediated Dilation

  Baseline, Day 105, Day 137

• Change in Peripheral Arterial Stiffness

  Baseline, Day 105, Day 137

• Change in 24-hour Ambulatory Blood Pressure

  Baseline, Day 105, Day 137

• Change in C-reactive Protein

  Baseline, Day 105, Day 137

• Change in Fibrin Degradation Products

  Baseline, Day 105, Day 137

Study Arms (1)

Hypoglossal Nerve Stimulation Treatment Withdrawal

OTHER

Recipients of hypoglossal nerve stimulation (HGNS) who agree to participate in the study will have additional tests done to monitor cardiovascular responses to HGNS therapy and the temporary withdrawal of treatment.

Device: Hypoglossal Nerve Stimulation Treatment Withdrawal

Interventions

Hypoglossal Nerve Stimulation Treatment Withdrawal DEVICE

After 90 days of hypoglossal nerve stimulation (HGNS), therapy will be discontinued for 30 days before being reactivated.

Also known as: HGNS

Hypoglossal Nerve Stimulation Treatment Withdrawal

Eligibility Criteria

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

You may qualify if:

• English-speaking
• Able to give informed consent
• Apnea-hypopnea index (AHI) of 20 or more from recent sleep test
• Unable to use positive airway pressure therapy
• Body Mass Index (BMI) \< 32 kg/m2
• Without circumferential collapse on drug-induced sedated endoscopy

You may not qualify if:

• Active smokers
• Unstable and untreated coronary or peripheral artery disease
• Use of alpha-blockers
• Severe and inadequately controlled arterial hypertension

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory Sleep Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Raj Dedhia, MD, MS
• Organization: Emory University

raj.dedhia@emory.edu

(404) 778-3381

Study Officials

• Raj Dedhia, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Interpretation of all tests (sleep tests, ambulatory blood pressure monitoring, vascular test and blood tests) will be done by an outcomes assessor who is blinded to whether treatment is active or withheld at the time of testing.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All participants will undergo the intervention of temporary treatment withdrawal to examine cardiac measurements before treatment, during treatment, and after cessation.

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 13, 2017
• Study Start: November 21, 2016
• Primary Completion: December 14, 2017
• Study Completion: December 14, 2017
• Last Updated: December 11, 2018
• Results First Posted: December 11, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)