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New treatment option for Obstructive Sleep Apnea
Official title The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome)
ClinicalTrials.gov ID: NCT05237505
What this study is testing
What is Oxygen gas?
Oxygen gas is an investigational medicine, given as an once-weekly, being studied as a potential treatment for obstructive sleep apnea.
Also referred to as O2.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Major progress has been made in the area of cardiovascular disease, but we believe that further progress will involve mechanistically addressing underlying respiratory causes including chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA). The most common cause of death in COPD is cardiovascular, although mechanisms are unknown.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 79
You may be able to join if
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Persons aged 40-79.
- For women, only postmenopausal women will be included
- Diagnosed with untreated moderate to severe obstructive sleep apnea (apnea-hypopnea index ≥15 events/hr and ≤80 events/hr) and/or diagnosed with COPD...
You likely can't join if
- Premenopausal women (i.e. women are pregnant or may become pregnant) or lactation
- Presence of specific devices: cardiac implantable electronic device (CIED) such as pacemakers, implantable cardioverter defibrillators (ICDs) and...
- Known allergic reactions to components of the study intervention: (if getting contrast, MRI contrast (gadolinium)).
- Concurrent severe sleep disorders (such as periodic limb movements, restless legs syndrome, narcolepsy, idiopathic hypersomnia, etc).
- Exhibit Cheyne-Stokes respiration or central sleep apnea (\> 25 % of events central)
- Take potentially confounding medications or hormones that affect breathing.
See the full eligibility criteria
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Persons aged 40-79.
- For women, only postmenopausal women will be included
- Diagnosed with untreated moderate to severe obstructive sleep apnea (apnea-hypopnea index ≥15 events/hr and ≤80 events/hr) and/or diagnosed with COPD with FEV1/FVC ratio \<0.7 and will be on stable medications as...
- Premenopausal women (i.e. women are pregnant or may become pregnant) or lactation
- Presence of specific devices: cardiac implantable electronic device (CIED) such as pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices, metallic foreign bodies...
- Known allergic reactions to components of the study intervention: (if getting contrast, MRI contrast (gadolinium)).
- Concurrent severe sleep disorders (such as periodic limb movements, restless legs syndrome, narcolepsy, idiopathic hypersomnia, etc).
- Exhibit Cheyne-Stokes respiration or central sleep apnea (\> 25 % of events central)
- Take potentially confounding medications or hormones that affect breathing.
- people will be excluded if they are deemed medically unstable with active neurological, cardiac, liver, endocrine, and infectious diseases.
- We will also exclude participants with pulmonary disease apart from COPD.
- We will exclude participants with active cancer treatment.
- We will exclude azotemia (estimated glomerular fraction rate \< 30ml/min) as there is some concern about giving gadolinium to these patients (if getting contrast MRI).
- people with exposures deemed to be problematic for the research e.g. any smoking in bedroom by participant or household member, major second-hand smoke, e-cigarettes, tetrahydrocannabinol, major drug or alcohol...
- Individuals who are already on continuous O2 for COPD or PAP treatment for OSA.
- Patients with sustained desaturations below 89% during wake time will be excluded for ethical reasons since withholding oxygen in hypoxemic patients would be at odds with standard of care.
- Individuals with OSA (AHI range 15-80/hr) will be screened for pathological sleepiness and will be excluded if ESS \>18/24, history of motor vehicle accident or near miss accident, or high-risk occupation.
- COPD individuals with arterial PCO2 higher than 52 mmHg will be excluded.
- Individuals who are currently incarcerated.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.