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NCT Number: NCT01882257

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

* 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).

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Key information

Conditions

Obstructive Sleep Apnea Apnea Central Nervous System Diseases Dyssomnias Hypercapnia Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

BiPAP

Device

BiPAP-auto (Phillips Respironics)is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is used to treat obstructive sleep apnea.

Other names: BiPAP-auto (Phillips Respironics)

BiPAP/AVAPS (Phillips Respironics)

Device

BiPAP/AVAPS (Phillips Respironics) is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation due to an underlying neuromuscular disorder.

Primary outcomes

  1. Prevalence of Sleep-disordered Breathing in Spinal Cord-injured Adults

    Time frame: Month 4 after enrollment

    After enrollment, the subject completes symptom logs for four months to collect baseline data. At that point, the home-based sleep study is performed, and the results determine whether the subject has sleep-disordered breathing. The primary outcome to be measured in this study is to determine the prevalence and type of sleep-disordered breathing in subjects with spinal cord injury. These results in turn determine the type of positive pressure device to be prescribed, as detailed in the description of the study arms. Therefore, the arm distribution is itself a primary outcome of this study.

  2. The Frequency of Technical Errors Related to the Home-based Overnight Testing.

    Time frame: Overnight testing (4-13 hours)

    All testing was done overnight, and if the home-based overnight test was inadequate, that portion of the testing was repeated (also overnight).

Other outcomes

  1. Short Term Effects on Daily Symptoms and Medical Events

    Time frame: Months 0-16 after enrollment

    The subjects keep daily logs of certain symptoms and events (pulmonary symptoms that require escalated care, pulmonary infections, doctor visits, hospitalizations, antibiotic use, symptoms of unstable blood pressure). These data are collected throughout the study period

  2. Short Term Effects of Noninvasive Ventilatory Support on Quality of Life

    Time frame: Months 4-16

    At month 4 of the study, and every 3 months therafter for 12 months, the subjects will complete standardized questionnaires on quality of life, focusing on general well being, mood, pain, and sleepiness.

  3. Short Term Effects of Noninvasive Ventilatory Support on Glucose and Lipid Metabolism

    Time frame: Months 4-16

    When home-based sleep testing is performed, and at 3, 6, and 12 months afterward, subjects will have blood tests to determine if treatment of sleep-disordered breathing has any effects on glucose intolerance/diabetes and/or blood cholesterol/lipid levels

  4. Identify Clinical Features That Are Predict or Are Associated With the Severity of Sleep-disordered Breathing

    Time frame: Month 4 after enrollment

    Clinical features (neck and waist circumference, body mass index, level and duration of spinal cord injury, lung function tests, questionnaire results) will be analyzed to determine if certain attributes predict the presence or severity of sleep-disordered breathing.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Jun 20, 2013
Registry last updated
Jan 11, 2017

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

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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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