Pulmonary Disease, Chronic ObstructiveNCT05606406
Hypoxia and Heart Rate Variability
A study testing Nocturnal Oxygen in people with Pulmonary Disease, Chronic Obstructive and Hypoxia, run by University of Miami at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Hypoxia
- What is being tested?
- Nocturnal Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2026to 29 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to provide consent
- Ability to provide consent
- Chronic respiratory condition resting Sat < 95% off oxygen
Who cannot join
- BMI > 40 kg/m2
- Prevalent myocardial infarction, coronary revascularization, heart failure, and stroke
- Unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, cancer, and active psychiatric disease (e.g., major depression)
- Nocturnal Hypoxemia
- BMI > 40 kg/m2
- Prevalent myocardial infarction, coronary revascularization, heart failure, and stroke
- Unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, severe chronic obstructive pulmonary disease, cancer, and active psychiatric disease (e.g., major depression)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Hypoxia
- Being tested
- Nocturnal Oxygen
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nocturnal OxygenOther
Nocturnal oxygen will be increased hourly for a period of four hours up to 4 liters per minute (LPM). If the oxygen saturation (SpO2) falls below 70% the oxygen rate will be increased until patients achieve the threshold of 70% and then will proceed with titrations of 1 liter per minute LPM per hour.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control Group | Active comparator | Individuals without lung disease will receive oxygen for a period of four hours Receives: Other: Nocturnal Oxygen |
| Nocturnal hypoxemia group | Active comparator | Individuals with lung disease will receive oxygen for a period of four hours Receives: Other: Nocturnal Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
QT Variability Index
Measured from electrocardiogram (ECG)
Measured: Up to 10 hours
Secondary outcomes (2)
Normalized variance of the heart rate (HRVN)
Measured from ECG
Measured: Up to 10 hours
QT-RR interval
Measured from ECG
Measured: Up to 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start30 May 2026 (estimated)
- Primary completion29 Jul 2026 (estimated)
- Study completion29 Jul 2026
Why it stopped: Study stopped due to no recruitment activities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trishul Siddharthan, University of Miami
- Investigators
- Trishul Siddharthan, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606406
- Sponsor's protocol ID
- 20220794
- Status last verified
- Jul 2026
- First submitted
- 1 Nov 2022
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoxia and Heart Rate Variability
- ClinicalTrials.gov ID
- NCT05606406
- Acronym / sponsor ID
- 20220794
- Conditions
- Pulmonary Disease, Chronic Obstructive, Hypoxia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study stopped due to no recruitment activities
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 29 Jul 2026 (estimated)
- Study completion
- 29 Jul 2026 (actual)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Control Group | Active comparator | Other: Nocturnal OxygenIndividuals without lung disease will receive oxygen for a period of four hours |
| Nocturnal hypoxemia group | Active comparator | Other: Nocturnal OxygenIndividuals with lung disease will receive oxygen for a period of four hours |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to provide consent
- Ability to provide consent
- Chronic respiratory condition resting Sat < 95% off oxygen
Key exclusion criteria (7 listed)
- BMI > 40 kg/m2
- Prevalent myocardial infarction, coronary revascularization, heart failure, and stroke
- Unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, cancer, and active psychiatric disease (e.g., major depression)
- Nocturnal Hypoxemia
- BMI > 40 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nocturnal OxygenNocturnal oxygen will be increased hourly for a period of four hours up to 4 liters per minute (LPM). If the oxygen saturation (SpO2) falls below 70% the oxygen rate will be increased until patients achieve the threshold of 70% and then will proceed with titrations of 1 liter per minute LPM per hour. | Other | Healthy Control Group, Nocturnal hypoxemia group |
Primary outcome
QT Variability Index
Time frame: Up to 10 hours
Measured from electrocardiogram (ECG)
2 secondary outcomes
Normalized variance of the heart rate (HRVN)
Time frame: Up to 10 hours
QT-RR interval
Time frame: Up to 10 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trishul Siddharthan, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nocturnal Oxygen in people with Pulmonary Disease, Chronic Obstructive and Hypoxia, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QT Variability Index (time frame: Up to 10 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.