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Effect of Supplemental Oxygen Therapy on Neurocognitive Performance in Healthy Highlanders (SPIRIT_1)

10. juni 2026 opdateret af: University of Zurich
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).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: SOT followed by Sham intervention
5L /min supplemental oxygen therapy through a nasal canula will be administered to the participants. The intervention will start 5 minutes before the neurocognitive assessments and will be administered throughout the assessment. After >4 hours of washout, the participants will repeat the neurocognitive assessments with 5 L/min sham intervention (room air).
Medicin: Supplemental oxygen therapy
5 L/min supplemental oxygen therapy administered through nasal canula.
Andet: Sham intervention
5 L/min sham intervention administered through nasal canula.
Sham-komparator: Sham intervention followed by SOT
5L /min sham intervention (room air) through a nasal canula will be administered to the participants. The intervention will start 5 minutes before the neurocognitive assessments and will be administered throughout the assessment. After >4 hours of washout, the participants will repeat the neurocognitive assessments with 5 L/min supplemental oxygen therapy.
Medicin: Supplemental oxygen therapy
5 L/min supplemental oxygen therapy administered through nasal canula.
Andet: Sham intervention
5 L/min sham intervention administered through nasal canula.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Psychomotor vigilance reaction time
Tidsramme: Comparison between SOT and sham after 15 minutes intervention
The difference in the reaction time during a 10-minute psychomotor vigilance test between SOT and Sham intervention.
Comparison between SOT and sham after 15 minutes intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Trail making test performance
Tidsramme: Comparison between SOT and sham after 15 minutes intervention
The difference in the trial making test A performance between SOT and Sham intervention.
Comparison between SOT and sham after 15 minutes intervention
Stroop test performance
Tidsramme: Comparison between SOT and sham after 15 minutes intervention
The difference in the stroop test performance between SOT and Sham intervention.
Comparison between SOT and sham after 15 minutes intervention
Digit Span test performance
Tidsramme: Comparison between SOT and sham after 15 minutes intervention
The difference in the digit span test performance between SOT and Sham intervention.
Comparison between SOT and sham after 15 minutes intervention
Go / No-Go test performance
Tidsramme: Comparison between SOT and sham after 15 minutes intervention
The difference in the Go / No-Go test performance between SOT and Sham intervention.
Comparison between SOT and sham after 15 minutes intervention
N-back test performance
Tidsramme: Comparison between SOT and sham after 15 minutes intervention
The difference in the n-back test performance between SOT and Sham intervention.
Comparison between SOT and sham after 15 minutes intervention
Task Switching Cued test performance
Tidsramme: Comparison between SOT and sham after 15 minutes intervention
The difference in the task switching cued test performance between SOT and Sham intervention.
Comparison between SOT and sham after 15 minutes intervention
Flanker test performance
Tidsramme: Comparison between SOT and sham after 15 minutes intervention
The difference in the Flanker test performance between SOT and Sham intervention.
Comparison between SOT and sham after 15 minutes intervention
Corsi Span test performance
Tidsramme: Comparison between SOT and sham after 15 minutes intervention
The difference in the Corsi span test performance between SOT and Sham intervention.
Comparison between SOT and sham after 15 minutes intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Zurich

Samarbejdspartnere

National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

Efterforskere

  • Ledende efterforsker: Michael Furian, University of Zurich
  • Ledende efterforsker: Edith M Schneider, Dr., University of Zurich

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

18. juni 2026

Primær færdiggørelse (Anslået)

31. juli 2026

Studieafslutning (Anslået)

31. juli 2026

Datoer for studieregistrering

Først indsendt

3. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SPIRIT_1

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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