30 Participants Needed

Hypercapnia Treatment for Sleep Apnea

(RECOV2SCI Trial)

AS
Overseen ByAbdulghani Sankari, MD PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of Hypercapnia Treatment for Sleep Apnea?

Research suggests that intermittent hypercapnia (increased carbon dioxide levels) may influence breathing stability during sleep, potentially improving conditions like sleep apnea. Studies indicate that combining intermittent hypercapnia with intermittent hypoxia (low oxygen levels) could help stabilize breathing and reduce sleep apnea severity.12345

Is hypercapnia treatment safe for humans?

Research on CO2 therapy for central sleep apnea shows it can improve sleep quality and reduce breathing issues without affecting heart rate, suggesting it may be safe for humans. However, more studies are needed to confirm its safety and effectiveness.36789

How does hypercapnia treatment for sleep apnea differ from other treatments?

Hypercapnia treatment for sleep apnea is unique because it involves controlled exposure to increased levels of carbon dioxide (CO2) to stabilize breathing patterns during sleep, unlike traditional treatments that focus on mechanical support or medication. This approach aims to enhance respiratory muscle training and improve breathing stability by leveraging the body's natural response to CO2 levels.23101112

What is the purpose of 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.

Research Team

AS

Abdulghani Sankari, MD PhD

Principal Investigator

John D. Dingell VA Medical Center, Detroit, MI

Eligibility Criteria

This trial is for adults with chronic spinal cord injury (SCI) who have been injured for over 6 months and are experiencing sleep-disordered breathing. They must be able to consent to the study themselves and not be too ill to participate. People with severe heart failure, recent substance abuse, or certain health events affecting sleep cannot join.

Inclusion Criteria

I have sleep apnea but no spinal cord injury or disorder.
I have had a spinal cord injury for more than 6 months and have some level of impairment.

Exclusion Criteria

My heart's pumping ability is severely reduced.
I've had a recent health event like a stroke or surgery that could affect my sleep.
Alcohol or substance abuse (<90 days sobriety)
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intermittent hypercapnia treatment five days per week for two weeks

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Hypercapnia treatment
  • Sham treatment
Trial Overview The trial is testing a new treatment approach for sleep apnea in patients with spinal cord injuries by using daily hypercapnia treatments over two weeks. The effectiveness of this treatment will be compared against a sham (fake) treatment.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: SCDExperimental Treatment1 Intervention
Intermittent hypercapnia treatment five days per week for two weeks.
Group II: Able-BodoedExperimental Treatment1 Intervention
Intermittent hypercapnia treatment five days per week for two weeks.
Group III: Intervention hypercapnia armActive Control1 Intervention
Intermittent hypercapnia treatment five days per week for two weeks.

Hypercapnia treatment is already approved in United States for the following indications:

🇺🇸
Approved in United States as Hypercapnia treatment for:
  • Sleep apnea in spinal cord injury
  • Respiratory recovery after spinal cord injury

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

VA Detroit Healthcare System

Collaborator

Trials
1
Recruited
30+

Detroit VA

Collaborator

Trials
1
Recruited
30+

Findings from Research

In a randomized trial involving 48 patients with moderate to severe sleep apnea, those treated with optimal CPAP showed significantly greater improvements in sleepiness and other SAHS-related symptoms compared to those receiving sham CPAP, confirming the efficacy of CPAP treatment.
The study demonstrated that even patients who initially received sham CPAP experienced significant improvements in symptoms when switched to optimal CPAP, highlighting the treatment's effectiveness in enhancing overall health and productivity.
Effectiveness of CPAP treatment in daytime function in sleep apnea syndrome: a randomized controlled study with an optimized placebo.Montserrat, JM., Ferrer, M., Hernandez, L., et al.[2022]
Intermittent hypercapnia can lead to long-term depression of respiration and may prevent the beneficial effects of long-term facilitation when combined with intermittent hypoxia, suggesting a complex interaction between these conditions.
Sustained hypercapnia, especially when paired with intermittent hypoxia, may improve breathing stability during sleep and could help address issues related to sleep apnea, highlighting its potential therapeutic relevance.
The impact of intermittent or sustained carbon dioxide on intermittent hypoxia initiated respiratory plasticity. What is the effect of these combined stimuli on apnea severity?Mateika, JH., Panza, G., Alex, R., et al.[2019]
In a study of 13 obese patients with sleep apnea, those with chronic hypercapnia showed reduced ventilatory responses to increased carbon dioxide and low oxygen levels, indicating a link between hypercapnia and impaired respiratory control.
Despite the presence of hypercapnia, there was no clear relationship between the severity of sleep apnea and the type or frequency of apneas, suggesting that other factors may influence apnea patterns in these patients.
Regulation of ventilation in the obstructive sleep apnea syndrome.Garay, SM., Rapoport, D., Sorkin, B., et al.[2016]

References

Effectiveness of CPAP treatment in daytime function in sleep apnea syndrome: a randomized controlled study with an optimized placebo. [2022]
The impact of intermittent or sustained carbon dioxide on intermittent hypoxia initiated respiratory plasticity. What is the effect of these combined stimuli on apnea severity? [2019]
Regulation of ventilation in the obstructive sleep apnea syndrome. [2016]
Evaluation of sham-CPAP as a placebo in CPAP intervention studies. [2022]
Potential mechanism for transition between acute hypercapnia during sleep to chronic hypercapnia during wakefulness in obstructive sleep apnea. [2021]
Impact of adherence with positive airway pressure therapy on hypercapnia in obstructive sleep apnea. [2018]
[Mechanisms of diurnal hypercapnia in sleep apnea syndromes associated with morbid obesity]. [2016]
Central sleep apnea treated by a constant low-dose CO2 supplied by a novel device. [2023]
Determinants of hypercapnia in obese patients with obstructive sleep apnea: a systematic review and metaanalysis of cohort studies. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Effects of stabilizing or increasing respiratory motor outputs on obstructive sleep apnea. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Medical treatment of obstructive sleep apnea. [2013]
12.United Statespubmed.ncbi.nlm.nih.gov
Obstructive sleep apnea with severe chronic airflow limitation. Comparison of hypercapnic and eucapnic patients. [2016]
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