Effects of Overnight Low Oxygen Exposure on Energy Balance (NCT04151927) | Clinical Trial Compass
CompletedNot Applicable
Effects of Overnight Low Oxygen Exposure on Energy Balance
United States20 participantsStarted 2019-12-11
Plain-language summary
This research study will evaluate changes in resting metabolic rate, appetite, and heart rate variability following overnight exposure (8 h/night) to normobaric hypoxia (NH) or normobaric normoxic (NN). In randomized order, participants will sleep one night in NH conditions (\~15% oxygen; achieved with nitrogen dilution, equivalent to \~8500 feet elevation) and another night in NN (control) conditions (\~20% oxygen; achieved with nitrogen dilution, equivalent to \~1000 feet elevation).
Who can participate
Age range20 Years – 45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men and women aged 20 - 45 years
* Body mass index between 18.5 - 24.5 kg/m2
* Born at altitudes less than 2,100 meters (\~7,000 feet)
* Currently residing in Tallahassee, Florida or the surrounding area
* Not taking any medication(s) that interfere with metabolism or oxygen delivery/transport for four weeks before and throughout the entire study (e.g., includes sedatives, sleeping aids, tranquilizers, and/or any medication that depresses ventilation, diuretics, alpha, and beta-blockers).
* Willing to refrain from smoking, vaping, chewing tobacco, and dietary supplement use throughout the entire study
* Willing to spend two overnight visits on the Florida State University campus.
Exclusion Criteria:
* Living in areas that are more than 1,200 m (\~4,000 feet), or have traveled to areas that are more than 1,200 m for five days or more within the last two months
* Metabolic or cardiovascular abnormalities, gastrointestinal disorders, or any condition that interferes with metabolism or oxygen delivery/transport (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
* Prior diagnosis of apnea or other sleeping disorders
* Prior diagnosis of high-altitude pulmonary edema or high-altitude cerebral edema
* Prior diagnosis of anemia or sickle cell anemia/trait
* Present condition of alcoholism, anabolic steroid, or other substance abuse issues
* Women who are pregnant, lactating, planning to become pregnant, or who have had an irregular menstrual cycle…
What they're measuring
1
Resting metabolic rate (kcal/d) following exposure to NH or NN conditions