Impact of Nocturnal Hypoxemia on Glucose in High Altitude Sleep Disordered Breathing

NCT05462834 | Withdrawn DMC

• 2 other identifiers: IRB00329264K23HL155730
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Glucose Intolerance; Sleep-Disordered Breathing

Outcome Measures

Primary Outcomes (1)

• Mean glucose level

  average glucose (mg/dL) during sleep assessed via continuous glucose monitoring

  14 days after start of intervention

Secondary Outcomes (6)

• Mean fasting glucose level

  14 days after start of intervention

• Mean fasting insulin

  14 days after start of intervention

• Morning blood pressure

  14 days after start of intervention

• Inflammatory marker interleukin-6 (IL-6)

  14 days after start of intervention

• Tumor Necrosis Factor alpha (TNF-a) level in blood (picogram/milliliter)

  14 days after start of intervention

Study Arms (2)

Compressed Air then Supplemental Oxygen

EXPERIMENTAL

Other: Compressed Air; Other: Supplemental Oxygen

Supplemental Oxygen then Compressed Air

EXPERIMENTAL

Other: Compressed Air; Other: Supplemental Oxygen

Interventions

Compressed Air OTHER

Participants will be instructed to use compressed air during sleep as a placebo control.

Compressed Air then Supplemental Oxygen; Supplemental Oxygen then Compressed Air

Supplemental Oxygen OTHER

Participants will be instructed to use supplemental oxygen at rate of 2lpm during sleep.

Compressed Air then Supplemental Oxygen; Supplemental Oxygen then Compressed Air

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Permanent residents of Puno, Peru

You may not qualify if:

• Recent travel to low altitude (\<3000 m)
• Oxygen use
• Pregnancy
• Morbid obesity (BMI \> 40 kg/m2)
• Current smoking
• Diabetes
• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institutes of Health (NIH): collaborator
• PRISMA A.B.: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

MeSH Terms

Conditions

Sleep Apnea Syndromes; Glucose Intolerance

Interventions

Compressed Air

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Air; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• Luu Pham, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 intervention periods lasting 14 days, separated by a 7-day washout

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 18, 2022
• Study Start: December 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share