Acclimatization of Healthy Subjects During a Stay at 3200 m | NCT02451020

Studies
Acclimatization of Healthy Subjects During a Stay at 3200 m

NCT02451020

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Oct 30, 2018Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Effects of High Altitude

Interventions

Altitude exposure

Countries

Kyrgyzstan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 8, 2015Actual

Primary Completion Date

Aug 9, 2015Actual

Completion Date

Aug 9, 2015Actual

First Submitted Date

May 18, 2015

First Submission Date that Met QC Criteria

May 20, 2015

First Posted Date

May 21, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2018

Last Update Posted Date

Oct 30, 2018Actual

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

This study evaluates the effect of 3 weeks altitude acclimatization on sleep related breathing disturbances in healthy subjects staying at 3200 m. Participants living in Bishkek, Kyrgyzstan (700 m), will be transferred by car within 4 h to the Tuja Ashu high altitude clinic (3200 m). Outcomes will be assessed repeatedly during the stay at 3200 m.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Altitude exposure	Experimental	Stay at 3200 m for 3 weeks	Other: Altitude exposure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Altitude exposure	Other	Participants will stay for 3 weeks at an altitude of 3200 m	Altitude exposure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Mean nocturnal oxygen saturation measured by pulse oximetry	Difference in mean nocturnal oxygen saturation between night 1 at 3200 and night 1 at 700 m	night 1 at 3200 m
Mean nocturnal oxygen saturation measured by pulse oximetry

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Konrad E Bloch, MD	University Hospital, Zürich	Study Chair
Talant M Sooronbaev, MD	National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Center of Cardiology and Internal Medicine		Bishkek		720040	Kyrgyzstan

Condition Browse Module

MeSH Terms

ID	Term
D000532	Altitude Sickness
D000860	Hypoxia

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided