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

This study has been completed.
Sponsor:
Information provided by:
Ohio State University
ClinicalTrials.gov Identifier:
NCT00679757
First received: May 15, 2008
Last updated: June 9, 2010
Last verified: June 2010
  Purpose

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
Obstructive Sleep Apnea
Non-healing Wounds

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: The Prevalence and Implications of Obstructive Sleep Apnea in the Population of a Wound Center

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Risk of having sleep apnea. [ Time Frame: Immediate ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Wound healing ability. [ Time Frame: Immediate ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: January 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients of the OSU Wound Center

Criteria

Inclusion Criteria:

  • OSU Wound Clinic Patient

Exclusion Criteria:

  • Unable to complete survey
  • Under 18yrs old
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00679757

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

Publications:

Responsible Party: Dr. Rami Khayat, The Ohio State University
ClinicalTrials.gov Identifier: NCT00679757     History of Changes
Other Study ID Numbers: 2007H0242
Study First Received: May 15, 2008
Last Updated: June 9, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014