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Not yet recruiting NCT07651917

Effect of Supplemental Oxygen Therapy on Neurocognitive Performance in Healthy Highlanders

Phase IV Interventional Neurocognition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Supplemental oxygen therapy, Sham intervention.
Who it may be relevant to
Registry conditions: Neurocognition. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Exposure to high altitudes, defined as locations above 2500 m, has been shown to cause cognitive alternations due to reduced blood oxygenation (SpO2). However, it remains to be determined whether cognitive changes are present in highlanders living at moderate altitudes (2500 m) and whether cognitive alterations are reversible with supplemental oxygen therapy (SOT).

Interventions

  • Drug Supplemental oxygen therapy
    5 L/min supplemental oxygen therapy administered through nasal canula.
  • Other Sham intervention
    5 L/min sham intervention administered through nasal canula.

Primary outcome measures

  • Psychomotor vigilance reaction time [Time frame: Comparison between SOT and sham after 15 minutes intervention]
Secondary outcome measures (8)
  • Trail making test performance [Time frame: Comparison between SOT and sham after 15 minutes intervention]
  • Stroop test performance [Time frame: Comparison between SOT and sham after 15 minutes intervention]
  • Digit Span test performance [Time frame: Comparison between SOT and sham after 15 minutes intervention]
  • Go / No-Go test performance [Time frame: Comparison between SOT and sham after 15 minutes intervention]
  • N-back test performance [Time frame: Comparison between SOT and sham after 15 minutes intervention]
  • Task Switching Cued test performance [Time frame: Comparison between SOT and sham after 15 minutes intervention]
  • Flanker test performance [Time frame: Comparison between SOT and sham after 15 minutes intervention]
  • Corsi Span test performance [Time frame: Comparison between SOT and sham after 15 minutes intervention]

Eligibility criteria

Inclusion criteria

  • Signed written consent
  • Age >18
  • Kyrgyz ethnicity
  • Born, raised and living at approximately 2500 m
  • Native or fluent in Russian language

Exclusion criteria

  • Severe disease such as unstable hypertension, coronary heart disease, pulmonary diseases, others.
  • Regular use of medication that interfere with sleep or breathing such as benzodiazepines, opioids, acetazolamide
  • Heavy smoking of >20 cigarettes per day
  • Not able to read or adhere to the study protocol

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07651917 · SPIRIT_1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗