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OpenTrials
Completed

NCT Number: NCT00679757

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University

Columbus, Ohio, 43212, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • OSU Wound Clinic Patient

Exclusion criteria

  • Unable to complete survey
  • Under 18yrs old

Treatment and study plan

Primary outcomes

  1. Risk of having sleep apnea.

    Time frame: Immediate

Secondary outcomes

  1. Wound healing ability.

    Time frame: Immediate

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 19, 2008
Registry last updated
Jun 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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