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

This study is currently recruiting participants.
Verified June 2013 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Robert G. Sitrin, M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT01882257
First received: June 17, 2013
Last updated: NA
Last verified: June 2013
History: No changes posted
  Purpose
  • 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).

Condition Intervention
Obstructive Sleep Apnea
Hypercapnia
Spinal Cord Injury
Device: BiPAP

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Home-Based Diagnosis and Management of Sleep-Related Breathing Disorders in Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Prevalence of sleep-disordered breathing in spinal cord-injured adults [ Time Frame: Month 4 after enrollment ] [ Designated as safety issue: No ]
    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 frequency of technical errors related to the testing will also be noted at that time.


Other Outcome Measures:
  • Short term effects on daily symptoms and medical events [ Time Frame: Months 0-16 after enrollment ] [ Designated as safety issue: No ]
    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

  • Short term effects of noninvasive ventilatory support on quality of life [ Time Frame: Months 4-16 ] [ Designated as safety issue: No ]
    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.

  • Short term effects of noninvasive ventilatory support on glucose and lipid metabolism [ Time Frame: Months 4-16 ] [ Designated as safety issue: No ]
    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

  • Identify clinical features that are predict or are associated with the severity of sleep-disordered breathing [ Time Frame: Month 4 after enrollment ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Normal sleep breathing
Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention.
Experimental: BiPAP for sleep apnea
Patients whose home-based sleep study detects obstructive sleep apnea, but no nocturnal hypoventilation. Noninvasive ventilatory support will be prescribed according to standard clinical criteria.
Device: BiPAP

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.

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.

Other Names:
  • BiPAP-auto (Phillips Respironics)
  • BiPAP/AVAPS (Phillips Respironics)
Experimental: BiPAP for nocturnal hypoventilation
Patients whose home-based sleep study detects nocturnal hypoventilation in the presence or absence of obstructive sleep apnea. Noninvasive ventilatory support will be prescribed according to standard clinical criteria.
Device: BiPAP

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.

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.

Other Names:
  • BiPAP-auto (Phillips Respironics)
  • BiPAP/AVAPS (Phillips Respironics)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01882257

Contacts
Contact: Armando Kurili, BS, LRT/CRT (734) 763-6334 kuriliar@umich.edu

Locations
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Armando Kurili, LRT/CRT    734-763-6334    kuriliar@umich.edu   
Contact: Robert G Sitrin, MD    734-763-9077    rsitrin@umich.edu   
Principal Investigator: Robert G Sitrin, MD         
Sponsors and Collaborators
University of Michigan
  More Information

No publications provided

Responsible Party: Robert G. Sitrin, M.D., Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT01882257     History of Changes
Other Study ID Numbers: HUM00051504, W81XWH-11-1-0826
Study First Received: June 17, 2013
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
obstructive sleep apnea
sleep-disordered breathing
hypercapnia
spinal cord injury

Additional relevant MeSH terms:
Apnea
Respiratory Aspiration
Hypercapnia
Sleep Apnea Syndromes
Spinal Cord Injuries
Sleep Apnea, Obstructive
Wounds and Injuries
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on April 17, 2014