Effect of Hypercapnia Treatment on Respiratory Recovery After Spinal Cord Injury
RECOV2SCI
1 other identifier
interventional
30
1 country
1
Brief Summary
It is estimated that 1,275,000 people in the United States alone live with spinal cord injury, including around 100,000 Veterans with spinal cord injury, making the V.A. the largest integrated health care system in the world for spinal cord injuries injury care. New therapies are needed to prevent the morbidities and mortalities associated with the high prevalence of respiratory disorders in Veterans with spinal cord injury. The current research project and future studies would set the base for developing innovative therapies for this disorder. This proposal addresses a new therapeutic intervention for sleep apnea in spinal cord injury. The investigators hypothesized that daily hypercapnia treatments improve respiratory symptoms and alleviate sleep apnea in patients with chronic spinal cord injury. The investigators will perform a pilot study to examine the impact of daily hypercapnia treatments for-two week durations among Veterans with spinal cord injury. The investigators believe that this novel approach to treating sleep apnea and will yield significant new knowledge that improves the health and quality of life of these patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2022
CompletedFirst Posted
Study publicly available on registry
September 10, 2022
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
April 2, 2026
March 1, 2026
4 years
July 28, 2022
March 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recruitment rate
Determine the recruitment rate in the intervention arm and determine how many continue into the sham arm. (Number of patients enrolled and completed the study)
2 weeks
Secondary Outcomes (2)
Minute Ventilation
2 weeks
Change in sleep apnea severity
2 weeks
Study Arms (3)
Intervention hypercapnia arm
ACTIVE COMPARATORIntermittent hypercapnia treatment five days per week for two weeks.
SCD
EXPERIMENTALIntermittent hypercapnia treatment five days per week for two weeks.
Able-Bodoed
EXPERIMENTALIntermittent hypercapnia treatment five days per week for two weeks.
Interventions
Intermittent hypercapnia treatment five days per week for two weeks.
Eligibility Criteria
You may qualify if:
- Adult patients with chronic SCI/D (\>6 months post-injury)
- American Spinal Injury Association (ASIA) classification A-D who have evidence of SDB (excluding those with no evidence of a neurologic deficit based on ASIA classification)
- Able-bodied patients (without SCI/D0 who have OSA.
You may not qualify if:
- Receiving continuous mechanical ventilation (except PAP therapy which is considered usual treatment for SDB
- Severe congestive heart failure with ejection fraction \<35%
- Recent health event that may affect sleep
- stroke
- acute myocardial infarction
- recent surgery
- hospitalization
- Alcohol or substance abuse (\<90 days sobriety)
- Self-described as too ill to engage in study procedures
- Evidence of hypercapnia on spontaneous breathing (end-tidal CO2 \>50 mmHg)
- Unable to provide self-consent for participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, 48201-1916, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abdulghani Sankari, MD PhD
John D. Dingell VA Medical Center, Detroit, MI
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants (SCI N=10, SD N=10 and Able bodied N=10) will be undergo the intervention arm (acute intermittent hypercapnia)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2022
First Posted
September 10, 2022
Study Start
March 1, 2023
Primary Completion (Estimated)
February 28, 2027
Study Completion (Estimated)
February 28, 2027
Last Updated
April 2, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Within one year of the publication
Publications from research will be made available to the public through the national Library of Medicine PubMed within one year after the date of publication. Final data sets underlying all publications resulting form the proposed research will be shared outside if the following criteria is met: A limited Dataset will be created and shared pursuant to Data Use Agreement (DUA) appropriately limiting use for dataset and prohibiting the recipient from identifying or re-identifying any individuals whose data are included in the dataset.