CompletedPhase 4

Effects of Naltrexone on Nocturnal Breathing Patterns at Altitude

United States16 participantsStarted 2021-08-08

Plain-language summary

Sleep at altitude is often poor. The purpose of this study is to evaluate the effects of a single dose of the opioid antagonist, naltrexone, on sleep quality and periodic breathing after rapid ascent to \~3800m altitude.

Who can participate

Age range18 Years – 35 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy males or females
✓. Age 18 to 35 years of age
✓. Body-mass index (BMI) ≤ 27
✓. At least two weeks after full vaccination for Sars-CoV-2. Proof of vaccination will be determined by the investigators.

Exclusion criteria

✕. Current smoker or significant past smoking history (≥ 10 pack-years)
✕. History of COPD, interstitial lung disease or other pulmonary disease that in the opinion of the investigators would compromise the subject's safety at altitude
✕. History of obstructive sleep apnea, or other history of sleep disordered breathing, or previous use of nighttime continuous positive airway pressure (CPAP)
✕. Any history of chronic opioid use or prior abuse history
✕. Any history of alcohol abuse
✕. Use of any opioid substance (prescribed or otherwise) within 2-weeks of study enrollment
✕. Any medications that might, in the opinion of the investigators, interfere with or alter respiratory control, (e.g. acetazolamide). Use of oral contraceptive medications would be allowed as long as the study subject is on the same agent/dose during both arms of the study.
✕. Recent (within 3 weeks) exposure to altitudes ≥ 3,500 m at time of 1st altitude trip

What they're measuring

Nighttime oxygen saturation

Timeframe: Up to 60 days

Periodic Breathing

Timeframe: Up to 60 days

Epworth Sleepiness Scale

Timeframe: Up to 60 days

Stanford Sleepiness Scale

Timeframe: Up to 60 days

Groningen Sleep Quality Scale

Timeframe: Up to 60 days

Trial details

NCT IDNCT05037032

SponsorVA Loma Linda Health Care System

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2021-10-17

View on ClinicalTrials.gov More Altitude trials

Who can participate

Age range18 Years – 35 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy males or females
✓. Age 18 to 35 years of age
✓. Body-mass index (BMI) ≤ 27
✓. At least two weeks after full vaccination for Sars-CoV-2. Proof of vaccination will be determined by the investigators.

Exclusion criteria

✕. Current smoker or significant past smoking history (≥ 10 pack-years)
✕. History of COPD, interstitial lung disease or other pulmonary disease that in the opinion of the investigators would compromise the subject's safety at altitude
✕. History of obstructive sleep apnea, or other history of sleep disordered breathing, or previous use of nighttime continuous positive airway pressure (CPAP)
✕. Any history of chronic opioid use or prior abuse history
✕. Any history of alcohol abuse
✕. Use of any opioid substance (prescribed or otherwise) within 2-weeks of study enrollment
✕. Any medications that might, in the opinion of the investigators, interfere with or alter respiratory control, (e.g. acetazolamide). Use of oral contraceptive medications would be allowed as long as the study subject is on the same agent/dose during both arms of the study.
✕. Recent (within 3 weeks) exposure to altitudes ≥ 3,500 m at time of 1st altitude trip