An observational study in Obstructive Sleep Apnea, sponsored by Ohio State University. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-28.
Sponsored by Ohio State University · Observational
The investigators hypothesized that patients with Obstructive Sleep Apnea (OSA) who are free of any cardiovascular disease will have early microcirculatory changes that are unique to OSA, and therefore would resolve with treatment of OSA.
Impaired vascular regulation of the microcirculation is a consequence of Obstructive Sleep Apnea (OSA). Nitric Oxide (NO) related endothelial dysfunction occurs in OSA as the earliest vascular abnormality prior to the manifestation of vascular disease and it results in impaired vasodilatory response to hypoxia. These abnormalities have already been described in OSA patients. The role of oxidative stress in endothelial dysfunction is present in vascular disorders. The presence of oxidative stress in OSA patients is also well established. The effect of increased superoxide on endothelial function has also been described in the literature. The mechanism of this effect is unknown and is the focus of this research.
We hypothesized that patients with Obstructive Sleep Apnea (OSA) who are free of any cardiovascular disease will have early microcirculatory changes that are unique to OSA, and therefore would resolve with treatment of OSA.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 90 is below the median of 106 across 386 observational studies indexed under Apnea.
Browse Apnea studies →Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants: will be 36 patients with newly diagnosed OSA and 36 age and BMI matched controls.
Patients with OSA will be enrolled from the sleep disorders center at OSU among patients who underwent a recent (past 4 weeks) polysomnography that is positive for OSA, and never were treated with CPAP.
Inclusion criteria will be AHI > 15 events per hours.
Exclusion criteria:
patients diagnosed with obstructive sleep apnea who do not have existing cardiovascular disease
patients without obstructive sleep apnea who are matched in weight and age to the OSA patients
eNOS Expression
All measurements will be obtained upon diagnosis of OSA and 12 weeks after effective treatment with continuous positive airway pressure (CPAP). Controls will receive all measurements at baseline.
Time frame: Measured at basline and 3-months post-treatment (CPAP) initiation
Peroxynitrite Formation
All measurements will be obtained upon diagnosis of OSA and 12 weeks after effective treatment with continuous positive airway pressure (CPAP). Controls will receive all measurements at baseline.
Time frame: Measured at basline and 3-months post-treatment (CPAP) initiation
Superoxide Production
All measurements will be obtained upon diagnosis of OSA and 12 weeks after effective treatment with continuous positive airway pressure (CPAP). Controls will receive all measurements at baseline.
Time frame: Measured at basline and 3-months post-treatment (CPAP) initiation
Plasma BH2 and BH4 Levels
All measurements will be obtained upon diagnosis of OSA and 12 weeks after effective treatment with continuous positive airway pressure (CPAP). Controls will receive all measurements at baseline. The BH2/BH4 ratio will be measured using high pressure liquid chromatography (HPLC).
Time frame: Measured at basline and 3-months post-treatment (CPAP) initiation
Plasma ADMA Levels
All measurements will be obtained upon diagnosis of OSA and 12 weeks after effective treatment with continuous positive airway pressure (CPAP). Controls will receive all measurements at baseline. Plasma ADMA levels will be measured using high pressure liquid chromatography (HPLC).
Time frame: Measured at basline and 3-months post-treatment (CPAP) initiation
This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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