N/A
N=74
Home-Based Diagnosis and Management of Sleep-Related Breathing Disorders in Spinal Cord Injury
Obstructive Sleep Apnea · Hypercapnia · Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT01882257 ↗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
| Outcome | Result | p-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
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.