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

NCT ID: NCT05462834

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2025-12-01

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

Sleep-Disordered Breathing; Glucose Intolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Compressed Air then Supplemental Oxygen

Group Type: EXPERIMENTAL

Compressed Air

Intervention Type: OTHER

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

Supplemental Oxygen

Intervention Type: OTHER

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

Supplemental Oxygen then Compressed Air

Group Type: EXPERIMENTAL

Compressed Air

Intervention Type: OTHER

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

Supplemental Oxygen

Intervention Type: OTHER

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

Interventions

Compressed Air

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

Intervention Type: OTHER

Supplemental Oxygen

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Permanent residents of Puno, Peru

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

PRISMA A.B.

UNKNOWN

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luu Pham, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Other Identifiers

K23HL155730

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00329264

Identifier Type: -

Identifier Source: org_study_id