Sleep-Disordered BreathingNCT05462834
Impact of Nocturnal Hypoxemia on Glucose in High Altitude Sleep Disordered Breathing
A study testing Compressed Air and Supplemental Oxygen in people with Sleep-Disordered Breathing and Glucose Intolerance, run by Johns Hopkins University.
Trial summary
Sleep disordered breathing is associated with impaired glucose tolerance and incident diabetes. Nocturnal hypoxemia is a potential stimulus of glucose intolerance. It is especially severe and highly prevalent in high altitude residents. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep-Disordered Breathing, Glucose Intolerance
- What is being tested?
- Compressed Air and Supplemental Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Dec 2025
- 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
- Permanent residents of Puno, Peru
Who cannot join
- Recent travel to low altitude (<3000 m)
- Oxygen use
- Pregnancy
- Morbid obesity (BMI > 40 kg/m2)
- Current smoking
- Diabetes
Show all 9Show fewer
- Other sleep disorders (e.g. circadian rhythm disorder or insomnia)
- Use of open fires in the home (i.e. for cooking or heat)
- Chronic Mountain Sickness (CMS) as defined by a daytime oxyhemoglobin saturation < 85%, Qinghai CMS >10 or excessive erythrocytosis as defined by hemoglobin >19 g/dL in women or >21 g/dL in men.
About this study
Sleep disordered breathing is associated with impaired glucose tolerance and incident diabetes. Nocturnal hypoxemia is a potential stimulus of glucose intolerance. It is especially severe and highly prevalent in high altitude residents. Intervening on nocturnal hypoxemia may therefore improve glucose control and decrease the public health burden in high altitude populations.
The objective of this study is to examine the impact of hypoxemia on glucose homeostasis in high altitude residents. The investigators will address this objective by examining the effect of supplemental oxygen on glucose in a randomized cross-over study.
- Conditions
- Sleep-Disordered Breathing, Glucose Intolerance
- Being tested
- Compressed Air, Supplemental Oxygen
- Medical subject headings
- Sleep Apnea Syndromes, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compressed AirOther
Participants will be instructed to use compressed air during sleep as a placebo control.
Supplemental OxygenOther
Participants will be instructed to use supplemental oxygen at rate of 2lpm during sleep.
| Study group | Role | What they receive |
|---|---|---|
| Compressed Air then Supplemental Oxygen | Experimental | Not described Receives: Other: Compressed Air; Other: Supplemental Oxygen |
| Supplemental Oxygen then Compressed Air | Experimental | Not described Receives: Other: Compressed Air; Other: Supplemental Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean glucose level
average glucose (mg/dL) during sleep assessed via continuous glucose monitoring
Measured: 14 days after start of intervention
Secondary outcomes (6)
Mean fasting glucose level
Mean fasting glucose level (mg/dL)
Measured: 14 days after start of intervention
Mean fasting insulin
Fasting insulin (U/mL)
Measured: 14 days after start of intervention
Morning blood pressure
Morning blood pressure (mmHg)
Measured: 14 days after start of intervention
Inflammatory marker interleukin-6 (IL-6)
Inflammatory marker interleukin-6 (IL-6) (pg/mL) level in plasma assessed by electrochemiluminescence as a measure of systemic inflammation
Measured: 14 days after start of intervention
Tumor Necrosis Factor alpha (TNF-a) level in blood (picogram/milliliter)
Tumor Necrosis Factor alpha level in blood as a marker of inflammation
Measured: 14 days after start of intervention
C-Reactive Protein (CRP) level in blood (mg/L)
C-Reactive Protein (CRP) level in blood as a marker of inflammation
Measured: 14 days after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 Dec 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Why it stopped: Changes in foreign component policy at NIH.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep-Disordered BreathingStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Randomised
- Intervention model
- Crossover
- Model description
- 2 intervention periods lasting 14 days, separated by a 7-day washout
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), PRISMA A.B., National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Luu Pham, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462834
- Sponsor's protocol ID
- IRB00329264
- Other IDs
- K23HL155730
- Status last verified
- Jan 2026
- First submitted
- 14 Jul 2022
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nocturnal Hypoxemia on Glucose in High Altitude Sleep Disordered Breathing
- ClinicalTrials.gov ID
- NCT05462834
- Acronym / sponsor ID
- IRB00329264
- Conditions
- Sleep-Disordered Breathing, Glucose Intolerance
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changes in foreign component policy at NIH.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), PRISMA A.B., National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 18 Jul 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.
Sleep disordered breathing is associated with impaired glucose tolerance and incident diabetes. Nocturnal hypoxemia is a potential stimulus of glucose intolerance. It is especially severe and highly prevalent in high altitude residents. Intervening on nocturnal hypoxemia may therefore improve glucose control and decrease the public health burden in high altitude populations.
The objective of this study is to examine the impact of hypoxemia on glucose homeostasis in high altitude residents. The investigators will address this objective by examining the effect of supplemental oxygen on glucose in a randomized cross-over study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 2 intervention periods lasting 14 days, separated by a 7-day washout
| Arm | Type | Receives |
|---|---|---|
| Compressed Air then Supplemental Oxygen | Experimental | Other: Compressed Air, Other: Supplemental Oxygen |
| Supplemental Oxygen then Compressed Air | Experimental | Other: Compressed Air, Other: Supplemental Oxygen |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Permanent residents of Puno, Peru
Key exclusion criteria (9 listed)
- Recent travel to low altitude (<3000 m)
- Oxygen use
- Pregnancy
- Morbid obesity (BMI > 40 kg/m2)
- Current smoking
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 |
|---|---|---|
| Compressed AirParticipants will be instructed to use compressed air during sleep as a placebo control. | Other | Compressed Air then Supplemental Oxygen, Supplemental Oxygen then Compressed Air |
| Supplemental OxygenParticipants will be instructed to use supplemental oxygen at rate of 2lpm during sleep. | Other | Compressed Air then Supplemental Oxygen, Supplemental Oxygen then Compressed Air |
Primary outcome
Mean glucose level
Time frame: 14 days after start of intervention
average glucose (mg/dL) during sleep assessed via continuous glucose monitoring
6 secondary outcomes
Mean fasting glucose level
Time frame: 14 days after start of intervention
Mean fasting insulin
Time frame: 14 days after start of intervention
Morning blood pressure
Time frame: 14 days after start of intervention
Inflammatory marker interleukin-6 (IL-6)
Time frame: 14 days after start of intervention
Tumor Necrosis Factor alpha (TNF-a) level in blood (picogram/milliliter)
Time frame: 14 days after start of intervention
C-Reactive Protein (CRP) level in blood (mg/L)
Time frame: 14 days after start of intervention
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 7 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Sleep-Disordered Breathing
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
RecruitingObservational study
Prediction of Tongue Base Obstruction During Sleep
Obstructive Sleep Disordered Breathing
RecruitingObservational study
Characterization of the Tongue in Children With Obstructive Sleep-disordered Breathing
Obstructive Sleep Disordered Breathing
Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
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.
Luu Pham, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Compressed Air and Supplemental Oxygen in people with Sleep-Disordered Breathing and Glucose Intolerance, run by Johns Hopkins University.
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 1 inclusion and 9 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 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Mean glucose level (time frame: 14 days after start of intervention). 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 7 Jan 2026.