Nocturnal Oxygen for Hypoxia

TS
Overseen ByTrishul Siddharthan, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Miami
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how nighttime oxygen levels affect heart activity in individuals with and without lung disease. Participants will receive nocturnal oxygen therapy for four hours while researchers study changes in heart function. This trial suits those with a chronic respiratory condition with low oxygen levels or healthy individuals who can give consent. As an unphased trial, it offers a unique opportunity to contribute to scientific understanding and potentially improve future treatments.

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 prior data suggests that nocturnal oxygen is safe for individuals with and without lung disease?

Research has shown that using oxygen at night is generally safe for people with lung disease. One study found that patients who used oxygen while sleeping had a lower risk of dying over two years compared to those who didn't use it. Another study found that using oxygen at night did not harm breathing during sleep, even at high altitudes. While these studies suggest that using oxygen at night is usually well-tolerated, some people might still experience minor side effects. Always consult a healthcare provider to understand personal risks.12345

Why are researchers excited about this trial?

Most treatments for hypoxia in lung disease focus on daytime oxygen supplementation or medications to improve lung function. However, the use of nocturnal oxygen therapy is unique because it specifically targets low oxygen levels during sleep. This approach may help improve overall oxygen saturation and reduce complications that arise from nighttime hypoxia. Researchers are excited about this treatment because it could offer a more tailored and potentially more effective way to manage hypoxia, especially for those whose oxygen levels drop significantly during sleep.

What evidence suggests that nocturnal oxygen is effective for hypoxia?

This trial will compare the effects of nocturnal oxygen therapy in two groups: individuals with lung disease experiencing nocturnal hypoxemia and healthy individuals. Research has shown that using oxygen therapy at night might address certain issues caused by low oxygen levels during sleep. For example, one study found that it can improve the outlook for people with COPD, a lung disease, who have low oxygen at night, though it doesn't necessarily extend their lifespan. Another study discovered that using oxygen at night can prevent low oxygen levels and breathing problems during sleep for some people. However, some research did not find clear proof that using oxygen at night changes overall health outcomes, such as longevity or the need for long-term oxygen. In summary, while using oxygen at night may help with breathing problems during sleep, its broader benefits remain uncertain.26789

Who Is on the Research Team?

TS

Trishul Siddharthan, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Nocturnal hypoxemia groupActive Control1 Intervention
Group II: Healthy Control GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Citations

Prognostic value of oxygen inhalation therapy for simple ...Our results show that oxygen therapy improves the prognosis of COPD patients with nocturnal hypoxemia alone, but does not improve survival, ...
Randomized Trial of Nocturnal Oxygen in Chronic ...Our underpowered trial provides no indication that nocturnal oxygen has a positive or negative effect on survival or progression to long-term oxygen therapy in ...
Effect of Nocturnal Oxygen Therapy on Nocturnal Hypoxemia ...This randomized clinical trial evaluates whether nocturnal oxygen therapy (NOT) prevents nocturnal hypoxemia and breathing disturbances among lowlanders with ...
Sleep-disordered Breathing in Patients with Chronic ...Results: Among 428 patients with COPD, OSA and nocturnal hypoxemia were ruled out in 41%, whereas 27% had iNH and 32% had OSA (i.e., COPD/OSA “ ...
Evaluating nocturnal oxygen desaturation in COPD – revisedA total of 49 patients (38%; 95% CI: 30%–47%) met our criterion for nocturnal desaturators without evidence of sleep apnea. Among these 49 patients, 5 would ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40085143/
Effect of an Overnight Stay at 2500 Meters on Nocturnal ...Conclusions: In stable, low-risk patients with pulmonary vascular disease, altitude worsened nocturnal hypoxemia but not sleep-disordered breathing. The ...
Home Oxygen Therapy for Adults with Chronic Lung ...The NOTT (3) study of 203 participants indicates a 2-year mortality-risk reduction of 55% in those prescribed LTOT (24 h/d) compared with control subjects ...
Effect of nocturnal oxygen therapy on exercise ...This trial evaluates whether nocturnal oxygen therapy (NOT) during a stay at 2048 m improves altitude-induced exercise intolerance in lowlanders with chronic ...
Effect of Nocturnal Oxygen Therapy on Daytime Pulmonary ...We investigated whether nocturnal oxygen therapy (NOT) mitigates the increase of pulmonary artery pressure in patients during daytime with chronic obstructive ...
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