Observational study · Summer 2026

SAAS-10@CRM

Somatic Alertness and Acute Mountain Sickness: investigating sex-based differences in symptom reporting at the Capanna Regina Margherita (4,554 m)

4,554 m Altitude
N ≥ 480 Participants
9–12 min Per participant
Monte Rosa · Italian Alps
Why this study?
The puzzle of mountain sickness and sex

Acute mountain sickness (AMS) is measured via questionnaires — what you feel and report. But if men and women perceive and report symptoms differently, are you measuring biology or perception?

Are women biologically more susceptible?

Some studies suggest a higher AMS prevalence in women, but the literature is conflicting. Hormonal and vascular sex differences may play a role — but that is just one explanation.

Or do they report differently?

Previous IRT analyses on the Annapurna Circuit showed comparable scale functioning but a trend toward different gastrointestinal symptom reporting. Perceptual differences could partly explain the "sex gap".

Somatic alertness as the key

We measure somatic alertness: the tendency to notice, interpret, and report bodily signals. If this differs between men and women, it could co-determine symptom scores.

From hypoxia to symptom score

AMS scores are a composite signal. This model shows how physiology, perception, and reporting style collectively determine the measurement outcome.

Hypoxic exposure

4,554 m hypobaric hypoxia, exertion, acclimatization status

Physiological response

SpO₂ drop, heart rate change, hyperventilation

Somatic alertness

Monitoring, catastrophic interpretation, behavioral response (SAAS-10)

Reported score

LLS-total, AMS-C

♀♂ Biological sex can exert influence at every level: physiology, perception, and reporting
Study design
One measurement point, maximum focus

Cross-sectional observational study. All measurements take place ≥ 4 hours after arrival at the hut, during the initial phase of symptom development.

Location

Capanna Regina Margherita (4,554 m), Monte Rosa massif, Italian Alps. Europe's highest mountain hut, with a long research tradition in altitude medicine.

Timing

Assessment takes place ≥ 4 hours after arrival. This ensures a uniform exposure duration while capturing early symptom development.
Data collection: July – August 2026. Expected inclusion: 30–45 participants per day.

Design

Single-site, cross-sectional, observational. No intervention, no invasive procedures. One standardized measurement moment per participant.

Data

Electronic data collection via Castor EDC (GCP-compliant). Paper back-up in case of connectivity issues. Fully anonymized — no personal data is stored.
Measurement instruments
What do we measure?

A combination of demographic data, validated questionnaires, and non-invasive physiological measurements (7–10 min per participant).

Background

General Questions

Essential basic data: biological sex, age, and previous mountain experience (acclimatization history).

New

SAAS-10

Somatic Alertness at Altitude Scale. Measures the tendency to notice, interpret, and report bodily signals.

AMS Score

Lake Louise Score

International standard for AMS. Scores headache, gastrointestinal symptoms, fatigue, and dizziness.

Symptom profile

ESQ-III / AMS-C

Environmental Symptoms Questionnaire. Weighted calculation for cerebral mountain sickness symptoms.

Covariate

Borg RPE

Rating of Perceived Exertion. Separates exertion-related fatigue from hypoxia symptoms.

Physiology

SpO₂ & HR

Peripheral oxygen saturation and heart rate via Nonin clinical pulse oximeter on the finger.

Study population
Who can participate?

All adult mountaineers present at the Capanna Regina Margherita during the 2026 research season.

≥ 480 Recruitment target
30 / 70 Expected ♀/♂ ratio (%)
≥ 18 Minimum age (years)

Inclusion criteria

  • Present at CRM (4,554 m)
  • Age ≥ 18 years
  • Assessment possible ≥ 4 hours after arrival
  • Informed consent provided
  • Sufficient English proficiency for questionnaires

Exclusion criteria

  • Age < 18 years
  • Insufficient English proficiency
  • Severe AMS / suspected HACE or HAPE
  • Altered consciousness or ataxia
  • Previous participation this season
Procedure
What do you do as a participant?

Participation is simple, voluntary, and takes only 9–12 minutes. Everything takes place in the hut.

Step 1

Recruitment

The researcher explains the study and asks for participation

Step 2

Scan QR code

Scan the QR code on the poster in the hut or you will be approached by the researcher

Step 3

Informed consent

Read the information and provide digital consent via Castor EDC

Step 4

Questionnaires

Complete the demographics, LLS, ESQ-III, BORG, and SAAS-10 digitally (~9 min)

Step 5

SpO₂ & heart rate

Short non-invasive measurement with finger sensor (~2 min)

Statistical analysis
How do we analyze the data?

The primary analysis tests whether somatic alertness (SAAS-10) is associated with AMS severity, and whether this association differs between men and women.

Multivariable regression models

The primary inference is based on two parallel regression models for the continuous outcome measures of mountain sickness severity: the Lake Louise Score (LLS) and the AMS-C score.

These models test the association between somatic alertness (SAAS-10) and AMS severity, adjusting for prespecified covariates: age, previous altitude experience, use of analgesics or acetazolamide, and physical exertion (Borg score).

Because the exact distribution of the outcomes is fully mapped only after data collection, the definitive statistical method (generalized linear modeling) is chosen based on the observed data properties. The Sex × SAAS-10 interaction term formally tests whether the relationship between somatic alertness and reported symptoms differs between men and women.

Secondary: clinical diagnosis

Logistic regression for exceeding diagnostic thresholds: LLS ≥ 3 + headache and AMS-C ≥ 0.7. Supportive, non-primary inference.

Psychometrics: SAAS-10

Initial validation: exploratory factor analysis (polychoric correlations), internal consistency, and SAAS-8 sensitivity analysis (excluding reversed items 9 and 10).

Ethics & regulations

Conducted in accordance with the Declaration of Helsinki (2024), WMO, GDPR, and UAVG. Approval requested from the LUMC ethics committee.

Privacy

Fully anonymous — no name, no identifiable data. Unique, automatically generated participant ID. After submission, data cannot be traced back.

Risks

No invasive procedures. No clinical interventions. Risk is negligible. Participation takes 9–12 minutes and must never delay medical care.

Open Science

Protocol pre-registered on OSF. Anonymized datasets will be made available upon publication (CC BY-NC-SA 4.0).