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NCT06499714
Prospective cohort study investigating the menstrual cycle phase (MCP)-dependent incidence of acute mountain sickness (AMS) in women travelling to 3600 m.
NCT06450899
This study is a trial looking at a drug to help prevent acute mountain sickness. The drug is prochlorperazine, a drug commonly used to treat nausea vomiting and headache. Participants will either take the drug or a placebo, and hike to and sleep at the summit of Mount Blue Sky located at 4,348 meters (14,265 feet).
NCT04993729
The specific aim of this double blind, randomized phase III trial is to evaluate the safety and efficacy of T89 in preventing Acute Mountain Sickness (AMS) and relieving the symptoms of AMS after rapid ascent.
NCT06039475
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 1. Material \& Methods: 1. Whether study involves Human/animals or both : Human 2. 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 3. Type of study design: : Case Control Study 4. Human study : Inclusion Criteria: 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. Exclusion Criteria: * Those who deny consent for participation. * Age\<18 years * Pregnant Women 5. Expected sample size : Sample size calculation: Mentioned in methodology 6. Control groups : N/A 7. Probable duration of study: 180 days 8. Setting: Emergency Ward 9. Parameter/Variables to be applied/measured Independent Variables i. Socio-demographic characteristics such as age, sex, address, nationality. Dependent Variables: i. Symptoms of Presentation ii. Ascent Rate iii. Co-morbidities iv. Past History including previous history of altitude sickness v. Personal History such as smoking, alcohol intake, recreational drugs vi. Awareness on High Altitude Sickness vii. Intake of Prophylactic medicine (Acetazolamide) viii. Past history of Covid-19 , TB Outcome measures: Primary (main outcome): All dependent variables (i) Rational for statistical methods to be employed : Data will be entered in Microsoft Excel and converted it into SPSS for statistical analysis . Descriptive statistics will be used to summarize the characteristics of cases and controls. Univariate and multivariate logistic regression analyses will be performed to assess the association between risk factors and high altitude sickness. The results will be reported as odds ratios with corresponding 95% confidence intervals. A p-value of less than 0.05 will be considered statistically significant. (ii) Ethical clearance : Ethical clearance will be obtained from National Health Research Council of Nepal (iii) Permission to use copyright questionnaire/Pro forma: Not applicable (j) Maintain the confidentiality of subject Confidentiality of the participants will be maintained. Whether available resources are adequate: Yes 1. Other resources needed: No 2. For Intervention trial: Not applicable
NCT06310642
A field-based trial was conducted to determine if oral prochlorperazine demonstrates efficacy in the prophylactic treatment of AMS, and/or decreases the incidence of the symptoms of acute mountain sickness including headache, GI symptoms, fatigue and dizziness based on data collected in the Lake Louise AMS score.
NCT03956472
The purpose of this research is to support a hypothesis that osteopathic manual medicine (OMM) and / or a 10 cmH2O end-expiratory pressure (PEEP) could be used in the prevention of acute mountain sickness (AMS). During altitude exposure, an exaggerated hypoxemia and the increase of intracranial pressure are both known to be major physipathological ways of AMS development. The goal of the osteopathic protocol is to release tension on the circulatory structures directly related to cranial circulation and drainage. The main hypothesis is that it could lead to lower intracranial pressure and help reducing AMS signs. Furthermore the investigators would like to define a osteopathic score for individual AMS sensitivity, based on cranial bones mobility. Several studies have shown that using PEEP at altitude (or hypoxia) increases SpO2. As for osteopathy protocol, the investigators would like to apply this experimental condition during real altitude exposure in a randomized controlled protocol.
NCT03828474
The specific aim of this study is to evaluate whether acetazolamide 125mg daily is no worse than acetazolamide 250mg daily in decreasing the incidence of acute mountain sickness (AMS) in travelers to high altitude. The study population is hikers who are ascending at their own rate under their own power in a true hiking environment at the White Mountain Research Station, Owen Valley Lab (OVL) and Bancroft Station (BAR), Bancroft Peak, White Mountain, California
NCT01794078
Acute exposure of the unacclimatized human body to high altitude leads to health complications, such as loss of exercise performance capacity and fatigue. The investigators have found that the combination of the xanthine drug theophylline and the endothelin receptor antagonist ambrisentan improves the exercise performance capacity of rats under simulated high altitude. In young, healthy human volunteers, this combination of drugs has not increase toxicity over the single compounds under sea-level conditions. The aim of this study is to test whether the combination of theophylline, supplied as its more soluble formulation aminophylline, and ambrisentan, are also safe to take under simulated high altitude of 4,267 meters, under both resting and exercising conditions. The study also aims to test whether this drug combination improves exercise capacity in humans. In this study, human subjects will be randomized to one of four treatment sequences and receive the same study drug(s) throughout all procedures. The study consists of an initial exercise test, followed by two cycles of drug testing at simulated high altitude: Cycle 1 - resting subjects receiving study drug at simulated altitude and continually monitored for safety with pharmacodynamic and pharmacokinetic assessments; and Cycle 2, the same as Cycle 1, with the addition of exercise testing. It is hypothesized that the combination of aminophylline and ambrisentan is not only safe under simulated high altitude, but also improves exercise performance capacity, in comparison with placebo.
NCT01682551
This trial is aimed to evaluate the effects of "Wu Zhu Yu Tang" on the prevention of Acute Mountain Sickness(AMS).
NCT01565603
Mechanisms underlying high-altitude intolerance as well as exercise performance limitation in hypoxia still remain to be fully understood. Recent data suggest that sleep disturbances on one hand and cerebral perturbations on teh other hand may be key mechanisms. The investigators evaluated 12 healthy subjects at sea level and at 4400 m of altitude for 7 days in order to better describe sleep and cerebral responses. The investigators hypothesized that sleep and cerebral disturbances play a critical role for the developement of acute mountain sickness and for exercise performance limitation during acute high-altitude exposure.
NCT00559832
Acclimatization by mountaineering prior to high altitude sojourns have shown to be effective in prevention of acute mountain sickness (AMS). The aim of this study is to investigate whether intermittent exposure to normobaric hypoxia during sleep is also effective to prevent AMS.