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Sleep-Disordered Breathing in Chronic SCI

Primary Purpose

Spinal Cord Injury, Sleep Apnea, Obstructive

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AutoPAP
Sham PAP
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Chronic tetraplegia or paraplegia (C4-L1)
  • American Spinal Injury Association (ASIA) Impairment Scale A, B, C or D
  • 18 years and older
  • At least one year post injury
  • Hearing and vision suitable for comprehension of instructions, and perception of cognitive test stimuli
  • No color blindness as measured by a brief screen with color perception Ishihara cards
  • Stable medical condition for 2 weeks prior to enrollment. Patients admitted to hospital will be eligible for enrolment if the acute illness precipitating admission is in recovery phase for 2 weeks or longer

Exclusion Criteria:

  • Diagnosis of SDB and successful positive airway pressure (PAP) therapy prior to injury. Those with a diagnosis of SDB post injury who are not receiving therapy for SDB (PAP, surgical, and/or oral appliance) are eligible for study enrollment
  • Patients who are intubated, have a tracheostomy, and/or are using long term invasive/non-invasive positive pressure ventilation
  • Participants with predominant central sleep apnea on PSG requiring bi-level PAP therapy
  • Severe traumatic brain injury (GCS < 8 at first assessment)
  • Unable to understand or read English at a grade 5 level
  • Inability to provide informed consent
  • Evidence of advanced neurological or systemic disease that may affect cognitive functioning (e.g., Alzheimer's disease, Dementia, Parkinson's disease)
  • Significant aphasia or language impairments
  • Positive airway pressure therapy may be contraindicated in some patients with the following preexisting conditions:
  • severe bullous lung disease
  • pneumothorax
  • pathologically low blood pressure
  • dehydration
  • cerebrospinal fluid leak, recent cranial surgery, or trauma.

Sites / Locations

  • Miami VA Hospital
  • Miami Project to Cure Paralysis, University of Miami Miller School of Medicine
  • John D Dingell VA Medical Center
  • Wayne State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

AutoPAP

Sham PAP

Arm Description

PAP treatment will be delivered for four months by an auto-titrating device (IntelliPAP AutoAdjust®). These devices automatically set the level of delivered pressure to ensure upper airway patency, to treat detected apneas and hypopneas.

Sham PAP treatment will be delivered for four months by an auto-PAP device (IntelliPAP AutoAdjust®) that is set to a fixed low pressure of 3 cmH20 without an ability to titrate according to detected respiratory events.

Outcomes

Primary Outcome Measures

Cognitive Functioning as Measured by PASAT
Paced Serial Addition Test (PASAT) measures divided attention and memory. PASAT has a total score ranging from 0 to 60 with the lower scores indicate greater impairment of attention.

Secondary Outcome Measures

Full Information

First Posted
June 25, 2014
Last Updated
October 29, 2020
Sponsor
University of Miami
Collaborators
United States Department of Defense, Wayne State University
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1. Study Identification

Unique Protocol Identification Number
NCT02176928
Brief Title
Sleep-Disordered Breathing in Chronic SCI
Official Title
Sleep-Disordered Breathing in Chronic SCI: A Randomized Controlled Trial of Treatment Impact on Cognition, Quality of Life, and Cardiovascular Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
United States Department of Defense, Wayne State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to examine impact of Sleep Disordered Breathing (SDB) treatment in persons with chronic Spinal Cord Injury (SCI). The central hypothesis is that the treatment of SDB with Positive Airway Pressure (PAP) will improve cognition, sleep quality, health related quality of life (HRQOL), pain and Cardiovascular Disease (CVD) surrogate measures in persons with chronic SCI.
Detailed Description
Investigators will examine the effect of PAP therapy and sleep apnea on thinking (especially memory, learning and concentration), sleep quality, and risks for future heart (cardiovascular) problems in persons with chronic spinal cord injury (SCI). SDB is a condition where there are pauses in breathing or shallow breathing during sleep due to airway narrowing. This leads to low oxygen levels during sleep and sleep disruption. The usual treatment for sleep apnea is PAP (Positive Airway Pressure) worn while sleeping. This involves the use of usually a mask connected to a machine that supplies enough pressure to keep the airway open during sleep. SDB will be diagnosed in SCI participants using unattended portable level II polysomnography (PSG) (a portable at home sleep study for one night). Sleep quality (SQ), SDB risk, insomnia severity, daytime sleepiness,and mood will be measured using questionnaires. Cognitive evaluations will be completed prior to randomization on all participants who also complete a portable PSG to evaluate general and pre-morbid function, immediate verbal memory, simple and sustained attention, processing speed, and executive function. Blood and urine samples will be taken for participants with SDB diagnosis after randomization. All randomized subjects will be fitted with a nasal or full-face mask and head gear. PAP will be delivered by an auto-titrating device. These devices automatically set the level of delivered pressure to ensure upper airway patency, to treat detected apneas, and hypopneas. All subjects will be instructed to use the device nightly during sleep, for the ensuing four months. All outcome measurements will be reassessed after four months of PAP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Sleep Apnea, Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AutoPAP
Arm Type
Active Comparator
Arm Description
PAP treatment will be delivered for four months by an auto-titrating device (IntelliPAP AutoAdjust®). These devices automatically set the level of delivered pressure to ensure upper airway patency, to treat detected apneas and hypopneas.
Arm Title
Sham PAP
Arm Type
Sham Comparator
Arm Description
Sham PAP treatment will be delivered for four months by an auto-PAP device (IntelliPAP AutoAdjust®) that is set to a fixed low pressure of 3 cmH20 without an ability to titrate according to detected respiratory events.
Intervention Type
Device
Intervention Name(s)
AutoPAP
Other Intervention Name(s)
IntelliPAP AutoAdjust®, CPAP
Intervention Description
PAP will be delivered by an auto-titrating device (IntelliPAP AutoAdjust®). These devices automatically set the level of delivered pressure to ensure upper airway patency, to treat detected apneas and hypopneas. AutoPAP treatment 7 nights a week for four months (16 weeks).
Intervention Type
Device
Intervention Name(s)
Sham PAP
Intervention Description
Sham PAP treatment will be delivered by an auto-PAP device (IntelliPAP AutoAdjust®) that is set to a fixed low pressure of 3 cmH20 without an ability to titrate according to detected respiratory events. The pressure is too low to eliminate respiratory events and serves as sham or sub-therapeutic PAP. Sham PAP treatment 7 nights a week for four months (16 weeks)./
Primary Outcome Measure Information:
Title
Cognitive Functioning as Measured by PASAT
Description
Paced Serial Addition Test (PASAT) measures divided attention and memory. PASAT has a total score ranging from 0 to 60 with the lower scores indicate greater impairment of attention.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Chronic tetraplegia or paraplegia (C4-L1) American Spinal Injury Association (ASIA) Impairment Scale A, B, C or D 18 years and older At least one year post injury Hearing and vision suitable for comprehension of instructions, and perception of cognitive test stimuli No color blindness as measured by a brief screen with color perception Ishihara cards Stable medical condition for 2 weeks prior to enrollment. Patients admitted to hospital will be eligible for enrolment if the acute illness precipitating admission is in recovery phase for 2 weeks or longer Exclusion Criteria: Diagnosis of SDB and successful positive airway pressure (PAP) therapy prior to injury. Those with a diagnosis of SDB post injury who are not receiving therapy for SDB (PAP, surgical, and/or oral appliance) are eligible for study enrollment Patients who are intubated, have a tracheostomy, and/or are using long term invasive/non-invasive positive pressure ventilation Participants with predominant central sleep apnea on PSG requiring bi-level PAP therapy Severe traumatic brain injury (GCS < 8 at first assessment) Unable to understand or read English at a grade 5 level Inability to provide informed consent Evidence of advanced neurological or systemic disease that may affect cognitive functioning (e.g., Alzheimer's disease, Dementia, Parkinson's disease) Significant aphasia or language impairments Positive airway pressure therapy may be contraindicated in some patients with the following preexisting conditions: severe bullous lung disease pneumothorax pathologically low blood pressure dehydration cerebrospinal fluid leak, recent cranial surgery, or trauma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirin Shafazand, MD, MS
Organizational Affiliation
University of Miami Miller School of Medicine; Pulmonary and Critical Care Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami VA Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Miami Project to Cure Paralysis, University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
John D Dingell VA Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29735608
Citation
Graco M, Schembri R, Cross S, Thiyagarajan C, Shafazand S, Ayas NT, Nash MS, Vu VH, Ruehland WR, Chai-Coetzer CL, Rochford P, Churchward T, Green SE, Berlowitz DJ. Diagnostic accuracy of a two-stage model for detecting obstructive sleep apnoea in chronic tetraplegia. Thorax. 2018 Sep;73(9):864-871. doi: 10.1136/thoraxjnl-2017-211131. Epub 2018 May 7.
Results Reference
derived

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Sleep-Disordered Breathing in Chronic SCI

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