An interventional study of sleep disruption and sleep with and without positive pressure in Obstructive Sleep Apnea and Metabolic Syndrome X, sponsored by National Institute on Aging (NIA). Status unknown at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-03-03.
Sponsored by National Institute on Aging (NIA) · Not applicable and Interventional
The purpose of this study is to define the mechanism(s) through which Obstructive Sleep Apnea/Hypopnea (OSAH) promotes abnormal metabolic processes which characterize the metabolic syndrome. The investigators hypothesize that the sleep fragmentation and intermittent sleep hypoxia which occur in OSAH patients promote oxidative stress and inflammation which in turn lead to insulin resistance, dyslipidemia, abnormal vascular reactivity and other processes which are consistent with the metabolic syndrome.
The metabolic syndrome has been defined as insulin resistance, central obesity, systemic hypertension and dyslipidemia and is associated with increased cardiovascular (CV) risk. Obstructive Sleep Apnea-Hypopnea (OSAH) is also associated with increased CV risk and insulin resistance. Since OSAH is associated with oxidative stress and pro-inflammatory processes, both of which are associated with insulin resistance, it follows that oxidative stress and inflammation may mediate the linkage between OSAH, insulin resistance and ultimately, the metabolic syndrome.
The overall goal of this research is to test the hypothesis that oxidative stress and inflammation link OSAH to insulin resistance as well as other CV risk-promoting conditions reflecting the metabolic syndrome (e.g. hyperlipidemia). We will specifically test if the individual sleep consequences of OSAH, including sleep fragmentation and intermittent sleep hypoxia, promote oxidative stress and inflammation which in turn promote insulin resistance and other features of the metabolic syndrome.
Aim 1a: To determine the effect of sleep fragmentation on oxidative stress and inflammation and features of the metabolic syndrome including insulin resistance, dyslipidemia, obesity, and hypertension.
Aim 1b: To assess the interaction between pre-existing metabolic syndrome and the overweight condition without metabolic syndrome, with regard to the effects of sleep fragmentation on the study variables, we will contrast the effect of experimentally-induced sleep fragmentation in non-OSAH/overweight individuals with the metabolic syndrome, non-OSAH/overweight individuals without metabolic syndrome and a control group of non-OSAH/normal weight without metabolic syndrome.
Aim: 2: To evaluate the effect of intermittent sleep hypoxia on oxidative stress and inflammation and explore the relationships between these two processes and insulin resistance, lipid profile, heart period variability and plasma cortisol.
Aim: 3: Using microarray data from peripheral monocytes, we will explore if specific gene expression patterns after the study conditions are associated with alterations consistent with metabolic syndrome.
Aim: 4: This exploratory aim is to collect preliminary data regarding the correlation among genetic variations (polymorphisms), gene expression patterns (microarray) and resultant protein production (proteomics). These data will be used for hypothesis development.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's planned enrollment of 76 is above the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →National Institute on Aging (NIA) is the lead sponsor of 157 studies on the registry; 13 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants With Sleep Apnea:
Exclusion Criteria:
non-OSAH/overweight individuals with the Metabolic Syndrome
Procedure: sleep disruption
non-OSAH/overweight individuals without Metabolic Syndrome
Procedure: sleep disruption
non-OSAH/normal weight without Metabolic Syndrome
Procedure: sleep disruption
OSAH patients with chronic positive airway pressure therapy
Procedure: sleep with and without positive pressure
OSAH patients without chronic positive airway pressure therapy
Procedure: sleep with and without positive pressure
experimentally-induced Sleep Fragmentation
OSAH patients with and without chronic positive airway pressure therapy
Also known as: fragmentation + normoxia, fragmentation + hypoxia
circulating and exhaled biomarkers of oxidative stress and pro-inflammatory cytokines, insulin resistance, lipid profile, plasma cortisol, and heart period variability (a reflection of sympathovagal tone)
Time frame: before and after 2 consecutive nights
This study is status unknown, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.
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National Institute on Aging (NIA)