Trial Outcomes & Findings for The Role of Oxidative Stress in the Cardiovascular Consequences of Sleep Apnea (NCT NCT00701441)

Results Overview

A non-invasive test using an ultrasound to measure baseline resting vessel diameter and vessel wall dilation in upper arm post application of an inflated blood pressure cuff for five minutes. The percentage change in vessel wall dilation due to stimulation from the resting vessel diameter will be calculated for each group of participants. The results will be compared relative to each group of participants.

Recruitment status

COMPLETED

Target enrollment

25 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2013-10-30

Participant Flow

Participant milestones

Participant milestones
Measure	Control No diagnosis of Obstructive Sleep Apnea or treatment with continuous positive airwary therapy	Obstructive Sleep Apnea Participants wear continuous positive airway therapy
Overall Study STARTED	9	16
Overall Study COMPLETED	9	12
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Control No diagnosis of Obstructive Sleep Apnea or treatment with continuous positive airwary therapy	Obstructive Sleep Apnea Participants wear continuous positive airway therapy
Overall Study failure in cpap compliance	0	4

Baseline Characteristics

The Role of Oxidative Stress in the Cardiovascular Consequences of Sleep Apnea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=9 Participants No diagnosis of Obstructive Sleep Apnea or treatment with continuous positive airwary therapy	Obstructive Sleep Apnea n=16 Participants Participants wear continuous positive airway therapy	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	16 Participants n=7 Participants	25 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	32.2 years STANDARD_DEVIATION 7.4 • n=5 Participants	43.6 years STANDARD_DEVIATION 11.2 • n=7 Participants	39.5 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	16 participants n=7 Participants	25 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: Comparative values analyzed for those with endothelial nitric oxide synthase and nitrotyrosine stain density values only.

A non-invasive test using an ultrasound to measure baseline resting vessel diameter and vessel wall dilation in upper arm post application of an inflated blood pressure cuff for five minutes. The percentage change in vessel wall dilation due to stimulation from the resting vessel diameter will be calculated for each group of participants. The results will be compared relative to each group of participants.

Outcome measures

Outcome measures
Measure	Obstructive Sleep Apnea-pre Treatment n=7 Participants Participants with Obstructive Sleep Apnea prior to receiving positive airway pressure treatment	Control n=7 Participants Participants with no diagnosis of obstructive sleep apnea and no treatment with continuous positive airway pressure	Obstructive Sleep Apnea Post Treatment n=7 Participants Participants with Obstructive Sleep Apnea after receiving positive airway pressure treatment for twelve weeks(% dilation change from baseline)
Flow Mediated Dilation	5.7 percentage change of vessel diamter Standard Error .5	9.5 percentage change of vessel diamter Standard Error .6	7.3 percentage change of vessel diamter Standard Error .9

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 12 weeks

Population: Comparative values analyzed for those with endothelial nitric oxide synthase and flow mediated dilation only.

A forearm biopsy will be collected to isolate human microcirculatory endothelial cells. The stain density of peroxynitrite, an indicator of oxidative stress, in the vascular walls is compared between pre-treatment and post treatment patient tissue. Also another comparison is made between pre-treatment and control tissue. The stain density is a software-generated measurement of pixel intensity and is considered to be an arbitrary unit. Higher numbers indicate greater density

Outcome measures

Outcome measures
Measure	Obstructive Sleep Apnea-pre Treatment n=7 Participants Participants with Obstructive Sleep Apnea prior to receiving positive airway pressure treatment	Control n=7 Participants Participants with no diagnosis of obstructive sleep apnea and no treatment with continuous positive airway pressure	Obstructive Sleep Apnea Post Treatment n=7 Participants Participants with Obstructive Sleep Apnea after receiving positive airway pressure treatment for twelve weeks(% dilation change from baseline)
Peroxynitrite Deposition in the Vascular Walls	44.0 stain density units Standard Error 1.6	21.8 stain density units Standard Error 1.9	30.5 stain density units Standard Error 1.6

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Obstructive Sleep Apnea

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rami Khayat

Ohio State University

Phone: 614-247-7707

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place