Health TrialsbyHealthPanel

Effect of Hypercapnia Treatment on Respiratory Recovery After Spinal Cord Injury

ConditionsSleep ApneaSCI/DHypercapnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hypercapnia treatment

    Other intervention

    Intermittent hypercapnia treatment five days per week for two weeks.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Intervention hypercapnia armActive comparator 1 intervention
Group B: SCDExperimental treatment 1 intervention
Group C: Able-BodoedExperimental treatment 1 intervention

Trial outcomes

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)

Time frame
2 weeks

Secondary outcomes

1

Minute Ventilation

To measure the change in minute ventilation (L/min)

Time frame
2 weeks
2

Change in sleep apnea severity

Severity of sleep apnea (Apnea-hypopnea index -events/hour)

Time frame
2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

VA Detroit Healthcare System

Collaborator

Source ClinicalTrials.gov
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