The Prevalence and Implications of Obstructive Sleep Apnea in the Population of a Wound Center

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00679757
Recruitment Status : Completed
First Posted : May 19, 2008
Last Update Posted : June 10, 2010
Information provided by:
Ohio State University

Brief Summary:
This study is looking at the prevalence of sleep apnea in a wound center population. It uses both screening surveys and take home devices. Some measures of wound healing ability are being looked at as well.

Condition or disease
Obstructive Sleep Apnea Non-healing Wounds

Detailed Description:

Patients with chronic non-healing wounds often have major co-morbidities such as diabetes and cardiovascular diseases [1]. Obstructive Sleep Apnea (OSA) is present in up to 24% of middle-aged adults [2], and is far more prevalent in patients with existing cardiovascular disease [3]. Patients with OSA are at increased risk of developing diabetes l [4]. OSA is an established cause of hypertension[5], and has an estimated prevalence of 40% in all patients with hypertension [6-8]. Similarly a strong association exists between OSA, coronary artery disease [6, 7] and stroke [8]. OSA may be present in over 50% of patients with heart failure [9]. Patients with chronic non-healing wounds stand to benefit from identification and treatment of severe co-morbidities such as OSA. Such identification and treatment of OSA will impact the survival of these patients [10, 11], and may also contribute to improved morbidity via impacting wound healing.

Several unexplored links exist between OSA and wound healing. OSA is a disorder of intermittent hypoxia and is associated with increased oxidative stress [12]. Humans with OSA and animal models of intermittent hypoxia developed impaired vascular function and nitric oxide deficiency. Patients with OSA have impaired endothelial function even in the absence of clinically apparent cardiovascular disease [13-15]. Increased sympathetic activity and episodic pressor response are well documented in OSA. Patients with OSA have increased vascular tone and baseline vasoconstriction [16]. Impaired vascular reactivity to hypoxia was also demonstrated in animal models exposed to 2 weeks of intermittent hypoxia[17]. Therefore, in patients with chronic non-healing wounds, OSA is likely to further complicate the healing process.

OSA as a disorder of oxidative stress and vascular impairment is most likely an important co-morbidity in patients with non-healing wounds. Other potential mechanisms of interaction are the inflammatory response associated with OSA

Study Type : Observational
Actual Enrollment : 300 participants
Time Perspective: Cross-Sectional
Official Title: The Prevalence and Implications of Obstructive Sleep Apnea in the Population of a Wound Center
Study Start Date : January 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Risk of having sleep apnea. [ Time Frame: Immediate ]

Secondary Outcome Measures :
  1. Wound healing ability. [ Time Frame: Immediate ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of the OSU Wound Center

Inclusion Criteria:

  • OSU Wound Clinic Patient

Exclusion Criteria:

  • Unable to complete survey
  • Under 18yrs old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00679757

United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43212
Sponsors and Collaborators
Ohio State University
Principal Investigator: Rami N Khayat, MD Ohio State University


Responsible Party: Dr. Rami Khayat, The Ohio State University Identifier: NCT00679757     History of Changes
Other Study ID Numbers: 2007H0242
First Posted: May 19, 2008    Key Record Dates
Last Update Posted: June 10, 2010
Last Verified: June 2010

Keywords provided by Ohio State University:
Sleep apnea
Obstructive sleep apnea
Wound healing
Non-healing wounds

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Wounds and Injuries
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases