Clinical trial NCT01882257: Home-Based Diagnosis and Management of Sleep-Related Breathing Disorders in Spinal Cord Injury
Official title: Home-Based Diagnosis and Management of Sleep-Related Breathing Disorders in Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Hypercapnia
Spinal Cord Injury
Keywords: obstructive sleep apnea
sleep-disordered breathing
hypercapnia
spinal cord injury
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-06-20
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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).

Detailed description: Eligible subjects will sign informed consent, followed by:

a 4 month period of maintaining a daily log of symptoms and medical events (such as hospitalization, starting antibiotics).

An overnight sleep study will be performed in the subject's home Based on the results of the sleep study, noninvasive ventilation (BiPAP) will be prescribed, according to standard medical practice. A clinical assessment, pulmonary function tests, and blood tests (blood glucose, hemoglobin A1C, and blood lipid profile) will be performed at the same time.

Quality of life surveys will be performed at months 0, 3, 6, and 12. The daily symptom logs will be continued for 12 months. Data from the BiPAP units will be downloaded and repeat overnight monitoring to measure blood oxygen and carbon dioxide levels will be performed periodically for 12 months after BiPAP is started.

Subjects without sleep-disordered breathing will have the same clinical assessments and blood tests as subjects for whom BiPAP has been described.

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

Primary outcomes:
measure: Prevalence of Sleep-disordered Breathing in Spinal Cord-injured Adults
timeFrame: Month 4 after enrollment
measure: The Frequency of Technical Errors Related to the Home-based Overnight Testing.
timeFrame: Overnight testing (4-13 hours)
Secondary outcomes:
Other outcomes:
measure: Short Term Effects on Daily Symptoms and Medical Events
timeFrame: Months 0-16 after enrollment
measure: Short Term Effects of Noninvasive Ventilatory Support on Quality of Life
timeFrame: Months 4-16
measure: Short Term Effects of Noninvasive Ventilatory Support on Glucose and Lipid Metabolism
timeFrame: Months 4-16
measure: Identify Clinical Features That Are Predict or Are Associated With the Severity of Sleep-disordered Breathing
timeFrame: Month 4 after enrollment
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Robert G Sitrin, Md
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bauman KA, Kurili A, Schotland HM, Rodriguez GM, Chiodo AE, Sitrin RG. Simplified Approach to Diagnosing Sleep-Disordered Breathing and Nocturnal Hypercapnia in Individuals With Spinal Cord Injury. Arch Phys Med Rehabil. 2016 Mar;97(3):363-71. doi: 10.1016/j.apmr.2015.07.026. Epub 2015 Aug 20.