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N/A N=74 Diagnostic

Home-Based Diagnosis and Management of Sleep-Related Breathing Disorders in Spinal Cord Injury

Obstructive Sleep Apnea · Hypercapnia · Spinal Cord Injury

Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Prevalence of Sleep-disordered Breathing in Spinal Cord-injured Adults — 40; 23; 11 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
BiPAP (Device); BiPAP/AVAPS (Phillips Respironics) (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Michigan
Primary completion
Dec 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Prevalence of Sleep-disordered Breathing in Spinal Cord-injured Adults
40; 23; 11
PRIMARY
The Frequency of Technical Errors Related to the Home-based Overnight Testing.
6; 9

Summary

* Patients with spinal cord injury (SCI) usually breathe without any mechanical assistance, but significant breathing problems occur often during sleep, either because the upper airway closes (obstructive sleep apnea; OSA), or because of weakness/paralysis of the breathing muscles. These problems often go unrecognized, as SCI patients face logistical barriers that cause them to refuse appropriate testing in sleep laboratories. We have devised a strategy for diagnosing sleep-disordered breathing in the patient's home, using placement of noninvasive devices that monitor breathing overnight. This project is designed to test the feasibility and utility of this strategy. * After collecting baseline data on symptoms and medical events for four months, the home-based studies are performed noninvasively with FDA-approved devices: a type III sleep system and a recording oxygen saturation/ transcutaneous carbon dioxide monitor. If these studies identify sleep-disordered breathing, noninvasive ventilatory support is prescribed according to standard clinical practice. Over the following twelve months, the subjects monitor their symptoms daily, and answer quality-of-life questionnaires every three months. After 3, 6, and 12 months, blood tests are performed to measure blood sugar and cholesterol/lipids. Data is downloaded from the ventilator device to monitor compliance and ventilator performance. This study is designed to determine the prevalence of sleep-disordered breathing in SCI, the feasibility of home-based testing to establish the diagnosis, and the short term effects on symptoms, quality-of-life, and associated conditions (glucose intolerance, blood lipid disorders).

Eligibility Criteria

Inclusion Criteria

  • 18 years or older
  • C1-T6 spinal cord injury for at least 3 months
  • living within 100 miles of Ann Arbor, Michigan, USA

Exclusion Criteria

  • unable to provide informed consent
  • comorbid condition that limits life expectancy to less than 1 year
  • ventilator-dependent
  • established diagnosis of sleep-disordered breathing
  • prior use of noninvasive positive pressure ventilation (CPAP or BiPAP) for any reason (temporary suse of noninvasive ventilation during a hospitalization is permissible if it was discontinued more than 3 months prior to enrollment)
  • active duty military personnel
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01882257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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