Acute Mountain SicknessTAIANCT03956472
Alternative Treatments in Acute Mountain Sickness
A study testing Osteopathic protocol for improving drainage of LCS, PEEP 10cmH2O and Fake Osteopathic protocol in people with Acute Mountain Sickness, run by Institut de Formation et de Recherche en Médecine de Montagne at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Mountain Sickness
- What is being tested?
- Osteopathic protocol for improving drainage of LCS, PEEP 10cmH2O and Fake Osteopathic protocol
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2017to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- Experienced alpinist
- No previous acclimatization
Who cannot join
- Heart failure, respiratory failure, kidney failure
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Osteopathy and Expiratory Resistance be Used in Prevention and/or Treatment of Acute Mountain Sickness ? a Randomized Controlled Field Study
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.
Read more
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.
- Conditions
- Acute Mountain Sickness
- Being tested
- Osteopathic protocol for improving drainage of LCS, PEEP 10cmH2O, Fake Osteopathic protocol, PEEP-Sham
- Keywords
- Altitude, Acute mountain sickness, Osteopathy, End expiratory pressure
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic protocol for improving drainage of LCSProcedure or surgery
Osteopathic intervention improving drainage of LCS and cerebral blood flow through opitmizing veinous circulation
PEEP 10cmH2ODevice
Breathing through a 10 cmH2O expiratory resistance for 10 min every 2 hours during 10h at 3842m high
Fake Osteopathic protocolOther
Placebo intervention
PEEP-ShamOther
PEEP 0 cmH2O (hidden)
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic group | Experimental | LCS Drainage before altitude exposure Receives: Procedure: Osteopathic protocol for improving drainage of LCS; Other: PEEP-Sham |
| PEEP 10 cmH2O | Experimental | 10 min at rest Receives: Device: PEEP 10cmH2O; Other: Fake Osteopathic protocol |
| Control group | Sham comparator | Sham PEEP and fake osteopathic protocol Receives: Other: Fake Osteopathic protocol; Other: PEEP-Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Lake Louise Score from baseline to altitude continuous exposure.
Signs of acute mountain sickness regarding its severity according the official Lake Louise Score.
Measured: mesured and reported every hour during a 10 hours altitude exposure
Secondary outcomes (1)
Changes in numeric scale of well being from baseline to altitude continuous exposure.
Quantification of general feeling on a scale from 0 (feeling as before ascent) to 10 (worst feeling)
Measured: every hour during a 10 hours altitude exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start17 Jun 2017
- Primary completion20 Oct 2018
- Study completion31 Jul 2019
Why it stopped: End of european funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Mountain SicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Formation et de Recherche en Médecine de Montagne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hugo Nespoulet, Institut de Formation et de Recherche en Médecine de Montagne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956472
- Sponsor's protocol ID
- TAIA
- Acronym
- TAIA
- Status last verified
- Aug 2021
- First submitted
- 16 Nov 2016
- Last updated
- 30 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Osteopathy and Expiratory Resistance be Used in Prevention and/or Treatment of Acute Mountain Sickness ? a Randomized Controlled Field Study
- ClinicalTrials.gov ID
- NCT03956472
- Acronym / sponsor ID
- TAIA / TAIA
- Conditions
- Acute Mountain Sickness
- Keywords
- Altitude, Acute mountain sickness, Osteopathy, End expiratory pressure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of european funding
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Institut de Formation et de Recherche en Médecine de MontagneUniversity, hospital or other
- Study start
- 17 Jun 2017 (actual)
- Primary completion
- 20 Oct 2018 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Osteopathic group | Experimental | Procedure: Osteopathic protocol for improving drainage of LCS, Other: PEEP-ShamLCS Drainage before altitude exposure |
| PEEP 10 cmH2O | Experimental | Device: PEEP 10cmH2O, Other: Fake Osteopathic protocol10 min at rest |
| Control group | Sham comparator | Other: Fake Osteopathic protocol, Other: PEEP-ShamSham PEEP and fake osteopathic protocol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy
- Experienced alpinist
- No previous acclimatization
Key exclusion criteria (2 listed)
- Heart failure, respiratory failure, kidney failure
- Pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic protocol for improving drainage of LCSOsteopathic intervention improving drainage of LCS and cerebral blood flow through opitmizing veinous circulation | Procedure or surgery | Osteopathic group |
| PEEP 10cmH2OBreathing through a 10 cmH2O expiratory resistance for 10 min every 2 hours during 10h at 3842m high | Device | PEEP 10 cmH2O |
| Fake Osteopathic protocolPlacebo intervention | Other | Control group, PEEP 10 cmH2O |
| PEEP-ShamPEEP 0 cmH2O (hidden) | Other | Control group, Osteopathic group |
Primary outcome
Changes in Lake Louise Score from baseline to altitude continuous exposure.
Time frame: mesured and reported every hour during a 10 hours altitude exposure
Signs of acute mountain sickness regarding its severity according the official Lake Louise Score.
1 secondary outcome
Changes in numeric scale of well being from baseline to altitude continuous exposure.
Time frame: every hour during a 10 hours altitude exposure
Results and safety
The study was stopped early (reason given: End of european funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic protocol for improving drainage of LCS, PEEP 10cmH2O and Fake Osteopathic protocol in people with Acute Mountain Sickness, run by Institut de Formation et de Recherche en Médecine de Montagne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: End of european funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Lake Louise Score from baseline to altitude continuous exposure. (time frame: mesured and reported every hour during a 10 hours altitude exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021; AzTrials last refreshed its copy on 6 Nov 2026.