NCT02451020

Brief Summary

The study evaluates respiratory acclimatization in healthy lowlanders staying for 3 weeks at 3200 m.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
18 days until next milestone

Study Start

First participant enrolled

June 8, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2015

Completed
Last Updated

October 30, 2018

Status Verified

October 1, 2018

Enrollment Period

2 months

First QC Date

May 18, 2015

Last Update Submit

October 29, 2018

Conditions

Effects of High Altitude

Keywords

healthy volunteersacclimatizationsleephypoxia

Outcome Measures

Primary Outcomes (1)

  • Mean nocturnal oxygen saturation measured by pulse oximetry

    Difference in mean nocturnal oxygen saturation between night 1 and night 7

    night 7 at 3200 m

Secondary Outcomes (3)

  • Mean nocturnal oxygen saturation measured by pulse oximetry

    night 1 at 3200 m

  • Mean nocturnal oxygen saturation measured by pulse oximetry

    night 21 at 3200 m

  • Mean nocturnal oxygen saturation measured by pulse oximetry

    night 1 at 700 m (low altitude baseline)

Study Arms (1)

Altitude exposure

EXPERIMENTAL

Stay at 3200 m for 3 weeks

Other: Altitude exposure

Interventions

Altitude exposureOTHER

Participants will stay for 3 weeks at an altitude of 3200 m

Altitude exposure

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Perfect health
  • Born, raised and currently living at low altitude (\<800m)
  • Informed consent.

You may not qualify if:

  • Any acute or chronic disease
  • heavy smoking (\>20 cigarettes per day).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Center of Cardiology and Internal Medicine

Bishkek, 720040, Kyrgyzstan

Location

MeSH Terms

Conditions

Altitude SicknessHypoxia

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Konrad E Bloch, MD

    University Hospital, Zürich

    STUDY CHAIR

  • Talant M Sooronbaev, MD

    National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2015

First Posted

May 21, 2015

Study Start

June 8, 2015

Primary Completion

August 9, 2015

Study Completion

August 9, 2015

Last Updated

October 30, 2018

Record last verified: 2018-10

Locations

KY(1)