Going to Altitude With Anxious-depressive Symptoms

Hypoxia Clinical Trial

— Psychoxie  

Official title:

Going to Altitude With Anxious-depressive Symptoms - a Randomised Cross Over Trial in Individuals With Mental Disorders and Healthy Controls

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05323864
• Other study ID #: 2022
• Status: Recruiting
• Phase: N/A
• Start date: April 14, 2023
• Est. completion date: May 2024

Study information

• Verified date: May 2023
• Source: Universitaet Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Introduction: Currently, there is a lack of international guidelines or clinical recommendations for individuals with mental illnesses (i.e., bipolar disorder, posttraumatic stress disorder) going on high altitude sojourns. However, these guidelines would be important considering that mental illnesses are among the most common disorders worldwide and millions of people are hiking at high altitudes in the Alps, being granted easy access up to 3800m by cable cars. Before conceptualizing these guidelines, it seems necessary to study the physiological and psychological effects of ambient pressure changes leading to oxygen deficiency (hypoxia) in individuals with mental illnesses when being exposed to hypoxic conditions. The investigators hypothesize a shift towards negative affective responses and state anxiety as well as increased levels of neurotransmitter precursor amino acids (PHE/TYR and KYN/TRP) in individuals with mental illnesses when being exposed to hypoxic conditions.

Methods and Analysis: The investigators plan to perform a double-blind randomized controlled trial in a safe laboratory environment by using a normobaric hypoxic chamber. Participants suffering from depression and anxiety symptoms will be included as well as age and sex-matched healthy controls. They will attend a six-hour exposure equivalent to 3800m of altitude as well as a six-hour exposure to sham hypoxic conditions. Recruited participants will be screened by the Beck Anxiety and Depression Inventory, the Symptom Checklist (SCL-90) as well as an interview assessment. Affective responses in state anxiety will be assessed before, and during each hour of exposure by using the Feeling Scale (FS), Felt Arousal Scale (FAS), Positive and Negative Affect Schedule (PANAS), State-Anxiety Inventory (STAI) and subjective mental stress levels (Visual Analogue Scale; VAS). Physiological parameters will be assessed by venous blood sampling, pulse oximetry and oxidative stress level measurement before entering the chamber, after three and six hours of exposure. Additionally, symptoms of acute mountain sickness will be assessed by the Lake Louise Score before, after three and six hours of exposure. Follow-up measurements are planned one and seven days after the chamber visit, consisting of venous blood sampling, the Beck Anxiety and Depression Inventory.

A series of univariate analyses of covariance (ANCOVA) for repeated measures will be used to test the three-way (i.e. "group × condition × time") and two-way ("group × condition" and "group × time") interactions. Analyses will be adjusted for possible confounding, by adding age, sex, smoking, prior AMS, and medication status in the models as covariates.

Ethics and dissemination: Ethical approval has been obtained from the ethics committee of the Medical University of Innsbruck (1250/2021).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: May 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• sufficient command of the German language

• no psychotic or cognitive disorders

• patients suffering from anxious-depressive symptoms (meeting the cut off points of light-medium in the screening for anxiety and depression symptoms)

Exclusion Criteria:

• pregnant or breastfeeding

• permanent residence above 1000m

• overnight stays at altitudes above 2500m in the previous month

• exposure to 2500m or higher two weeks prior to the six-hour hypoxic exposure

Related Conditions & MeSH terms

• Depression
• Hypoxia
• Mental Disorder
• Mental Disorders
• Psychotic Disorders

Intervention

Biological:
• Hypoxia
Participants will be randomly assigned to start with the normobaric hypoxia condition or the sham hypoxia condition. They will swap to the other condition during the second visit, which will be executed at least 14 days after the first visit. Each sojourn will last for six hours and participants will reside in the chamber individually. During the six-hour stay, participants will be allowed to move freely within the chamber.

Locations

Country	Name	City	State
Austria	University of Innsbruck, Department of Sport Science	Innsbruck	Tyrol

Sponsors (2)

Lead Sponsor	Collaborator
Universitaet Innsbruck	Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in affective responses	Self-reported questionnaire to assess affective valence, perceived activation, positive and negative affect	up to 6 hours, including 8 measurements, measuring before the start of intervention, every hour during the intervention, and after the end of intervention
Primary	Changes in state anxiety	Self-reported questionnaires to assess state anxiety	up to 6 hours, including 8 measurements, measuring before the start of intervention, every hour during the intervention, and after the end of intervention
Primary	Changes in subjective perception of stress	Self-reported questionnaires to assess subjective perception of stress	up to 6 hours, including 8 measurements, measuring before the start of intervention, every hour during the intervention, and after the end of intervention
Secondary	Changes in anxious-depressive symptoms	Self-reported questionnaires to assess depression symptoms, anxiety symptoms, and subjectively perceived impairment due to physical and psychological symptoms	10 days, including 3 measurements at baseline, day 1 and follow-up day 7
Secondary	Changes in inflammatory parameters CRP	Venous blood samples to assess CRP (C-reactive protein)	8 days, including 4 measurements pre intervention, after 3 hours of intervention, at the end of intervention (6 hours), and at follow-up after 7 days
Secondary	Changes in inflammatory parameters IL-6	Venous blood samples to assess IL-6 (interleukin 6)	8 days, including 4 measurements pre intervention, after 3 hours of intervention, at the end of intervention (6 hours), and at follow-up after 7 days
Secondary	Changes in oxidative stress	Capillary blood samples from the fingertip collected with the Free Carpe Diem device by DIACRON International to measure total antioxidant capacity and the antioxidant potential of plasma	6 hours, including 3 measurements, measuring pre intervention, after 3 hours of intervention, at the end of intervention (6 hours)