NCT06039475

Brief Summary

Research Title: RISK FACTORS ASSOCIATED WITH HIGH ALTITUDE SICKNESS: A CASE-CONTROL STUDY Rationale: The Study will help us to identify risk factors of high altitude sickness among Nepalese and International patients. Aims and Objectives:

  • To identify risk factors for high altitude sickness, including AMS, HACE, and HAPE.
  • To compare the prevalence of high altitude sickness between individuals who ascended rapidly versus those who ascended slowly.
  • To examine the association between high altitude sickness and various demographic and environmental factors, such as age, sex, altitude, and temperature.
  • To evaluate the effectiveness of preventative measures, such as gradual ascent and medication, in reducing the risk of high altitude sickness Research Hypothesis (if relevant): N/A
  • Material \& Methods:
  • Whether study involves Human/animals or both : Human
  • Population/ participants: Patients presenting in Emergency Ward of District Hospital, Mustang with AMS (Acute Mountain Sickness), HAPE (High altitude Pulmonary Oedema) or HACE (High altitude Cerebral Oedema) as CASES Healthy volunteers who didn't develop any symptoms of AMS/HAPE/HACE after their trip to high altitude as CONTROLS
  • Type of study design: : Case Control Study
  • Human study :
  • Those who deny consent for participation.
  • Age\<18 years
  • Pregnant Women
  • Expected sample size :
  • Control groups : N/A
  • Probable duration of study: 180 days
  • Setting: Emergency Ward
  • Parameter/Variables to be applied/measured Independent Variables i. Socio-demographic characteristics such as age, sex, address, nationality.
  • Other resources needed: No
  • For Intervention trial: Not applicable

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

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

Study Start

First participant enrolled

July 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

September 9, 2023

Last Update Submit

August 5, 2024

Conditions

Acute Mountain SicknessHigh Altitude Pulmonary EdemaHigh Altitude Cerebral Edema

Outcome Measures

Primary Outcomes (7)

  • Ascent Rate

    6 months

  • Awareness on High Altitude Sickness

    6 months

  • Personal History such as smoking, alcohol intake, recreational drugs

    6 months

  • Intake of Prophylactic medicine (Acetazolamide)

    6 months

  • Past history of Covid-19 , TB

    6 months

  • Past History including previous history of altitude sickness

    6 months

  • Co-morbidities

    6 months

Study Arms (2)

Case

Patients with AMS/HACE/HAPE

Control

Healthy Individuals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting in Emergency Ward of District Hospital, Mustang with AMS (Acute Mountain Sickness), HAPE (High altitude Pulmonary Oedema) or HACE (High altitude Cerebral Oedema) as CASES Healthy volunteers who didn't develop any symptoms of AMS/HAPE/HACE after their trip to high altitude

You may qualify if:

  • Cases: - Individuals age 18 years or older who have been diagnosed with AMS based on a LLS score of ≥3 or HAPE or HACE.
  • Controls: - Individuals age 18 years or older who did not develop AMS during their trip to high altitude as the cases, and who are matched to cases on age and sex.

You may not qualify if:

  • Those who deny consent for participation.
  • Age\<18 years
  • Pregnant Patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mustang District Hospital

Jomsom, Gandaki, Nepal

Location

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 9, 2023

First Posted

September 15, 2023

Study Start

July 1, 2023

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

August 6, 2024

Record last verified: 2024-08

Locations

NE(1)