Trial Outcomes & Findings for Effect of Upper Airway Stimulation on Vascular Function in Obstructive Sleep Apnea (NCT NCT03051165)
NCT ID: NCT03051165
Last Updated: 2018-12-11
Results Overview
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
TERMINATED
NA
13 participants
Baseline, Day 105, Day 137
2018-12-11
Participant Flow
Participants were recruited from the Emory Sleep Center in Atlanta, Georgia. Enrollment began on 11/21/2016 and the study was terminated early on 12/14/2017.
Participant milestones
| Measure |
Hypoglossal Nerve Stimulation Treatment Withdrawal
Recipients of hypoglossal nerve stimulation (HGNS) who consented to have temporary withdrawal of treatment.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
Completed Some Baseline Assessments
|
1
|
|
Overall Study
Completed Some Day 105 Assessments
|
1
|
|
Overall Study
Began HGNS Treatment Withdrawal
|
0
|
|
Overall Study
Completed Some Day 137 Assessments
|
0
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Hypoglossal Nerve Stimulation Treatment Withdrawal
Recipients of hypoglossal nerve stimulation (HGNS) who consented to have temporary withdrawal of treatment.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Early termination of study
|
12
|
Baseline Characteristics
Effect of Upper Airway Stimulation on Vascular Function in Obstructive Sleep Apnea
Baseline characteristics by cohort
| Measure |
Hypoglossal Nerve Stimulation Treatment Withdrawal
n=13 Participants
Recipients of hypoglossal nerve stimulation (HGNS) who consented to have temporary withdrawal of treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 105, Day 137Population: PAT assessment was not performed for any participants at any study visit.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 105, Day 137Population: One participant completed the flow mediated dilation assessment at Baseline and Day 105.
Flow mediated dilation is a method to assess endothelial function using an ultrasound device to take measurements of the artery at the elbow. Blood vessel diameter is measured before and after blood pressure cuff release and flow mediated dilation is the percent of change between the baseline and post cuff release measurements. A lower measurement of dilation corresponds with an increased risk for cardiovascular events.
Outcome measures
| Measure |
Hypoglossal Nerve Stimulation Treatment Withdrawal
n=1 Participants
Recipients of hypoglossal nerve stimulation (HGNS) who consented to have temporary withdrawal of treatment.
|
|---|---|
|
Change in Flow Mediated Dilation
Baseline (before initial device activation)
|
2.23 percentage of baseline arterial diameter
Standard Deviation 0.0
|
|
Change in Flow Mediated Dilation
Day 105 (after 90 days of device activation)
|
4.75 percentage of baseline arterial diameter
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Baseline, Day 105, Day 137Population: Peripheral arterial stiffness assessment was not performed for any participants at any study visit.
Recordings of blood flow through the artery in the wrist will be obtained with application of a probe applied to the skin. Participants will be seated or lying down for this test which takes approximately 10 minutes. Increased arterial stiffness is associated with an increased risk of cardiovascular events.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 105, Day 137Population: One participant completed the 24-hour ambulatory blood pressure Baseline assessment.
To measure 24-hour ambulatory blood pressure, participants wear a watch like device on one arm which records blood pressure throughout the day.
Outcome measures
| Measure |
Hypoglossal Nerve Stimulation Treatment Withdrawal
n=1 Participants
Recipients of hypoglossal nerve stimulation (HGNS) who consented to have temporary withdrawal of treatment.
|
|---|---|
|
Change in 24-hour Ambulatory Blood Pressure
Baseline Visit Systolic Blood Pressure
|
133 mm/Hg
Standard Deviation 0.0
|
|
Change in 24-hour Ambulatory Blood Pressure
Baseline Visit Diastolic Blood Pressure
|
67 mm/Hg
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Baseline, Day 105, Day 137Population: Blood for serum biomarker assessments was not collected for any participants at any study visit.
To assess changes in the serum biomarker profile, blood will be collected from participants to be stored for future analyses of a variety of biochemical factors related to cardiovascular function. C-reactive protein is produced by the liver and increased concentrations are found when inflammation is present in the body.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 105, Day 137Population: Blood for serum biomarker assessments was not collected for any participants at any study visit.
To assess changes in the serum biomarker profile, blood will be collected from participants to be stored for future analyses of a variety of biochemical factors related to cardiovascular function. Fibrin degradation products are produced by of clot degeneration. Plasma fibrin degradation products increase following clot formation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 105, Day 137Population: Blood for serum biomarker assessments was not collected for any participants at any study visit.
To assess changes in the serum biomarker profile, blood will be collected from participants to be stored for future analyses of a variety of biochemical factors related to cardiovascular function. Heat shock protein 70 (HSP70) is a stress protein. Heat shock proteins increase in response to stress conditions such as inflammation and infection.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 105, Day 137Population: Blood for serum biomarker assessments was not collected for any participants at any study visit.
To assess changes in the serum biomarker profile, blood will be collected from participants to be stored for future analyses of a variety of biochemical factors related to cardiovascular function. Elevated high sensitivity cardiac troponin (HS-troponin) indicates injury to the heart.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 105, Day 137Population: Blood for serum biomarker assessments was not collected for any participants at any study visit.
To assess changes in the serum biomarker profile, blood will be collected from participants to be stored for future analyses of a variety of biochemical factors related to cardiovascular function. Soluble urokinase-type plasminogen activator receptor (suPAR) is a marker for disease status by indicating the degree of activation of the immune system. Higher concentrations indicate inflammation and are associated with an increased risk of mortality.
Outcome measures
Outcome data not reported
Adverse Events
Hypoglossal Nerve Stimulation Treatment Withdrawal
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place