Nocturnal Oxygen for Hypoxia

Overseen By Trishul Siddharthan, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Obesity, Heart disease, Hypertension, Cancer, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

70 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate how variations in oxygen demands may change heart electrical activity in individuals with and without oxygen dependence.

Do I have to stop taking my current medications for the trial?

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.

What data supports the effectiveness of the treatment Nocturnal Oxygen for Hypoxia?

Research on nocturnal oxygen therapy in patients with chronic obstructive pulmonary disease (COPD) shows mixed results. While it did not significantly improve survival or delay the need for long-term oxygen therapy, it was effective in reversing hypoxemia (low blood oxygen levels) in 95% of stable COPD patients when used with nasal prongs delivering 1 to 3 L/min of oxygen. ^{1 2 3 4 5}

Is nocturnal oxygen therapy safe for humans?

Research on nocturnal oxygen therapy, particularly in patients with chronic obstructive pulmonary disease (COPD), suggests it is generally safe. Studies have monitored patients using nocturnal oxygen and found no significant safety concerns, although its effectiveness in improving outcomes like survival or delaying long-term oxygen therapy is still debated. ^{1 3 5 6 7}

How does nocturnal oxygen therapy differ from other treatments for hypoxia?

Nocturnal oxygen therapy is unique because it involves administering oxygen during sleep to improve oxygen levels in the blood, specifically targeting nighttime hypoxia. This approach is different from other treatments that may not focus on the timing of oxygen delivery or may not address the specific issue of low oxygen levels during sleep. ^{2 8 9 10 11}

Research Team

Trishul Siddharthan, MD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for individuals who can consent and have a chronic respiratory condition with oxygen saturation below 95% when not using supplemental oxygen. It's not for those with severe obesity, recent heart issues, uncontrolled medical conditions like angina or high blood pressure, cancer, or active major depression.

Inclusion Criteria

My oxygen levels fall below 95% when I'm not using supplemental oxygen.

Ability to provide consent

Exclusion Criteria

I have a history of heart attack, heart surgery, heart failure, or stroke.

I do not have uncontrolled heart issues, high blood pressure, cancer, or severe mental health conditions.

My BMI is over 40.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive oxygen for a period of four hours to evaluate heart electrical activity

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 10 hours

Treatment Details

Interventions

• Nocturnal Oxygen

Trial Overview The study is looking at how varying oxygen levels during the night affect heart electrical activity in people with chronic lung problems who do and don't use nighttime oxygen.

Participant Groups

Group I: Nocturnal hypoxemia group Active Control 1 Intervention

Individuals with lung disease will receive oxygen for a period of four hours

Group II: Healthy Control Group Active Control 1 Intervention

Individuals without lung disease will receive oxygen for a period of four hours

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

References

1. England pubmed.ncbi.nlm.nih.gov

A randomized trial of nocturnal oxygen therapy in chronic obstructive pulmonary disease patients. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Selection of patients with chronic obstructive pulmonary disease for long-term oxygen therapy. [2016]

3. China pubmed.ncbi.nlm.nih.gov

[Effects of nocturnal oxygen therapy and continuous positive pressure ventilation on nocturnal oxyhemoglobin desaturation of chronic obstructive pulmonary disease patients with acute exacerbation]. [2016]

4. Brazil pubmed.ncbi.nlm.nih.gov

Nocturnal desaturation: predictors and the effect on sleep patterns in patients with chronic obstructive pulmonary disease and concomitant mild daytime hypoxemia. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Sequential use of oxygen and bi-level ventilation for respiratory failure in cystic fibrosis. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Nocturnal hypoxemia and long-term oxygen therapy in COPD patients with daytime PaO2 60-70 mmHg. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Recruitment experience in the Nocturnal Oxygen Therapy Trial. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Oxygen Desaturation Index Estimation through Unconstrained Cardiac Sympathetic Activity Assessment Using Three Ballistocardiographic Systems. [2017]

9. England pubmed.ncbi.nlm.nih.gov

The contribution of hypoxia to the association between sleep apnoea, insomnia, and cardiovascular mortality in community-dwelling elderly with and without cardiovascular disease. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Snoring, nocturnal hypoxemia, and the effect of oxygen inhalation. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Day-night differences in oxygen saturation and the frequency of desaturations in the first 24 hours in patients with acute stroke. [2016]