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

Primary Purpose

Obstructive Sleep Apnea, Hypercapnia, Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BiPAP
BiPAP/AVAPS (Phillips Respironics)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, sleep-disordered breathing, hypercapnia, spinal cord injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Normal sleep breathing

BiPAP -Auto for sleep apnea

BiPAP (AVAPS) for nocturnal hypoventilation

Arm Description

Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention.

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.

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. BiPAP/AVAPS (Phillips Respironics) is worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation.

Outcomes

Primary Outcome Measures

Prevalence of Sleep-disordered Breathing in Spinal Cord-injured Adults
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.
The Frequency of Technical Errors Related to the Home-based Overnight Testing.
All testing was done overnight, and if the home-based overnight test was inadequate, that portion of the testing was repeated (also overnight).

Secondary Outcome Measures

Full Information

First Posted
June 17, 2013
Last Updated
January 10, 2017
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT01882257
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Hypercapnia, Spinal Cord Injury
Keywords
obstructive sleep apnea, sleep-disordered breathing, hypercapnia, spinal cord injury

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal sleep breathing
Arm Type
No Intervention
Arm Description
Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention.
Arm Title
BiPAP -Auto for sleep apnea
Arm Type
Experimental
Arm Description
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.
Arm Title
BiPAP (AVAPS) for nocturnal hypoventilation
Arm Type
Experimental
Arm Description
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. BiPAP/AVAPS (Phillips Respironics) is worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation.
Intervention Type
Device
Intervention Name(s)
BiPAP
Other Intervention Name(s)
BiPAP-auto (Phillips Respironics)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
BiPAP/AVAPS (Phillips Respironics)
Intervention Description
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 Outcome Measure Information:
Title
Prevalence of Sleep-disordered Breathing in Spinal Cord-injured Adults
Description
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.
Time Frame
Month 4 after enrollment
Title
The Frequency of Technical Errors Related to the Home-based Overnight Testing.
Description
All testing was done overnight, and if the home-based overnight test was inadequate, that portion of the testing was repeated (also overnight).
Time Frame
Overnight testing (4-13 hours)
Other Pre-specified Outcome Measures:
Title
Short Term Effects on Daily Symptoms and Medical Events
Description
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
Time Frame
Months 0-16 after enrollment
Title
Short Term Effects of Noninvasive Ventilatory Support on Quality of Life
Description
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.
Time Frame
Months 4-16
Title
Short Term Effects of Noninvasive Ventilatory Support on Glucose and Lipid Metabolism
Description
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
Time Frame
Months 4-16
Title
Identify Clinical Features That Are Predict or Are Associated With the Severity of Sleep-disordered Breathing
Description
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.
Time Frame
Month 4 after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert G Sitrin, Md
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26297810
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.
Results Reference
derived

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

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