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

Not Applicable

Not yet recruiting

• Conditions: Sleep-Disordered Breathing; Glucose Intolerance
• Interventions: Other: Compressed Air; Other: Supplemental Oxygen

• Registration Number: NCT05462834
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-14
• Study First Submitted QC: 2022-07-14
• Study First Posted: 2022-07-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-24
• Study Start: 2025-12-01
• Primary Completion: 2027-06-30
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Supplemental Oxygen then Compressed Air	Compressed Air	-
Compressed Air then Supplemental Oxygen	Compressed Air	-
Compressed Air then Supplemental Oxygen	Supplemental Oxygen	-
Supplemental Oxygen then Compressed Air	Supplemental Oxygen	-

Primary Outcome Measures

Name	Time	Method
Mean glucose level	14 days after start of intervention	average glucose (mg/dL) during sleep assessed via continuous glucose monitoring

Secondary Outcome Measures

Name	Time	Method
Tumor Necrosis Factor alpha (TNF-a) level in blood (picogram/milliliter)	14 days after start of intervention	Tumor Necrosis Factor alpha level in blood as a marker of inflammation
Inflammatory marker interleukin-6 (IL-6)	14 days after start of intervention	Inflammatory marker interleukin-6 (IL-6) (pg/mL) level in plasma assessed by electrochemiluminescence as a measure of systemic inflammation
Mean fasting glucose level	14 days after start of intervention	Mean fasting glucose level (mg/dL)
Mean fasting insulin	14 days after start of intervention	Fasting insulin (U/mL)
Morning blood pressure	14 days after start of intervention	Morning blood pressure (mmHg)
C-Reactive Protein (CRP) level in blood (mg/L)	14 days after start of intervention	C-Reactive Protein (CRP) level in blood as a marker of inflammation