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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01882257
First Posted: June 20, 2013
Last Update Posted: January 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Robert G. Sitrin, M.D., University of Michigan
Results First Submitted: November 4, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: Obstructive Sleep Apnea
Hypercapnia
Spinal Cord Injury
Interventions: Device: BiPAP
Device: BiPAP/AVAPS (Phillips Respironics)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
93 subjects were enrolled in the study. 2 subjects were found to be ineligible due to level of spinal cord injury. 91 patients remained in the study and were asked to keep daily logs of symptoms. 17 subjects were unable or unwilling to come to the first study visit.

Reporting Groups
  Description
Normal Sleep Breathing Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention.
BiPAP -Auto 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.

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

BiPAP/AVAPS (Phillips Respironics): 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.


Participant Flow for 2 periods

Period 1:   Study Origination to Beginning Therapy
    Normal Sleep Breathing   BiPAP -Auto for Sleep Apnea   BiPAP (AVAPS) for Nocturnal Hypoventilation
STARTED   11   40   23 
Started Therapy Using Device   11   38 [1]   22 [2] 
COMPLETED [3]   11   38   22 
NOT COMPLETED   0   2   1 
Withdrawal by Subject                0                2                1 
[1] Of the 40 who were given the device, 2 chose not to begin the actual therapy
[2] Of the 23 who were given the device, 1 chose not to begin the actual therapy
[3] Month 0 Visit Attended

Period 2:   Therapy Portion of Study (12 Months)
    Normal Sleep Breathing   BiPAP -Auto for Sleep Apnea   BiPAP (AVAPS) for Nocturnal Hypoventilation
STARTED   11   38   22 
COMPLETED [1]   11   27   18 
NOT COMPLETED   0   11   4 
Withdrawal by Subject                0                11                4 
[1] Completed Study, Month 12 Final Visit



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Normal Sleep Breathing Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention.
BiPAP -Auto 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.

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

BiPAP/AVAPS (Phillips Respironics): 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.

Total Total of all reporting groups

Baseline Measures
   Normal Sleep Breathing   BiPAP -Auto for Sleep Apnea   BiPAP (AVAPS) for Nocturnal Hypoventilation   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   40   23   74 
Age, Customized 
[Units: Participants]
       
18 to 75 years   11   40   23   74 
Gender 
[Units: Participants]
Count of Participants
       
Female      2  18.2%      5  12.5%      3  13.0%      10  13.5% 
Male      9  81.8%      35  87.5%      20  87.0%      64  86.5% 
Region of Enrollment 
[Units: Participants]
       
United States   11   40   23   74 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Prevalence of Sleep-disordered Breathing in Spinal Cord-injured Adults   [ Time Frame: Month 4 after enrollment ]

2.  Primary:   The Frequency of Technical Errors Related to the Home-based Overnight Testing.   [ Time Frame: Overnight testing (4-13 hours) ]

3.  Other Pre-specified:   Short Term Effects on Daily Symptoms and Medical Events   [ Time Frame: Months 0-16 after enrollment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Other Pre-specified:   Short Term Effects of Noninvasive Ventilatory Support on Quality of Life   [ Time Frame: Months 4-16 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Other Pre-specified:   Short Term Effects of Noninvasive Ventilatory Support on Glucose and Lipid Metabolism   [ Time Frame: Months 4-16 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Other Pre-specified:   Identify Clinical Features That Are Predict or Are Associated With the Severity of Sleep-disordered Breathing   [ Time Frame: Month 4 after enrollment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Although this study demonstrates that home-based overnight testing can identify sleep-disordered breathing in patients with spinal cord injury, it remains an individual clinical decision whether facility-based testing is preferable for some.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Robert G. Sitrin, M.D.
Organization: University of Michigan Health System
phone: (734) 936-5201
e-mail: rsitrin@umich.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Robert G. Sitrin, M.D., University of Michigan
ClinicalTrials.gov Identifier: NCT01882257     History of Changes
Other Study ID Numbers: HUM00051504
W81XWH-11-1-0826 ( Other Grant/Funding Number: Department of Defense )
First Submitted: June 17, 2013
First Posted: June 20, 2013
Results First Submitted: November 4, 2016
Results First Posted: January 4, 2017
Last Update Posted: January 11, 2017