Obesity, COPD, OHSNCT02636465
Hypoxia in Flight Simulation in Obese Patients
An observational study of Obesity, COPD, OHS, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.
Trial summary
The purpose of this pilot study is to determine whether obese adults,obese (BMI>30 kg/m2) with obesity hypoventilation or obese COPD-patients do undergo oxygen desaturation under flight simulation and if the hypoxic altitude simulation test is as effective as the hypoxic chamber test. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, COPD, OHS
- What is being tested?
- flight simulationin obese healthy adults or obese patients with or without COPD, OHS
- Type of treatment
- Injection or infusion
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2014to Feb 2015
- Phase
- Observational
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: obese (BMI>30 kg/m2) healthy adults, obese patients with obesity hypoventilation Syndrome, obese patients with COPD
Who may be able to join
- age ≥ 18 years
- patients with COPD (GOLD I-IV Group A-D) with obesity (BMI> 30kg/m2), obese healthy adults with BMI> 30kg /m2, patients with Obesity hypoventilation syndrome
- informed consent provided
Who cannot join
- patients less than BMI <30 kg/m2 with or without COPD, OHS
- Age < 18 years
- pregnancy, lactation
- any medical, psychological or other condition restricting the patient's ability to provide informed consent
- participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this pilot study is to determine whether obese adults,obese (BMI>30 kg/m2) with obesity hypoventilation or obese COPD-patients do undergo oxygen desaturation under flight simulation and if the hypoxic altitude simulation test is as effective as the hypoxic chamber test.
- Conditions
- Obesity, COPD, OHS
- Being tested
- flight simulationin obese healthy adults or obese patients with or without COPD, OHS
- Medical subject headings
- Obesity, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flight simulationin obese healthy adults or obese patients with or without COPD, OHSOther
Also called flight simulation
| Study group | Role | What they receive |
|---|---|---|
| obese healthy adults | persons with BMI> 30 kg/m2 Receives: Other: flight simulationin obese healthy adults or obese patients with or without COPD, OHS | |
| obese COPD patients | COPD-patients (GOLD I-IV Group A-D) with BMI> 30 kg/m2 Receives: Other: flight simulationin obese healthy adults or obese patients with or without COPD, OHS | |
| OHS-patients | patients with defined OHS: BMI>30 kg/m2 and sleep related breathing disease, no COPD Receives: Other: flight simulationin obese healthy adults or obese patients with or without COPD, OHS |
What is being measured
The primary outcome is the main question the study is designed to answer.
desaturation (SaO2 in %) in flight simulation in obese patients
Measured: one hour each patient
Secondary outcomes (1)
desaturation (SaO2 in %) in hypoxic chamber test versus hypoxia altitude Simulation test
Measured: one hour each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startMar 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obesity, COPD, OHSStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.V
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Luft und Raumfahrt
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636465
- Sponsor's protocol ID
- WI_105/2013
- Status last verified
- Nov 2015
- First submitted
- 2 Nov 2015
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Edvardsen A, Ryg M, Akero A, Christensen CC, Skjonsberg OH. COPD and air travel: does hypoxia-altitude simulation testing predict in-flight respiratory symptoms? Eur Respir J. 2013 Nov;42(5):1216-23. doi: 10.1183/09031936.00157112. Epub 2012 Dec 20.
PubMed 23258777Edvardsen A, Akero A, Christensen CC, Ryg M, Skjonsberg OH. Air travel and chronic obstructive pulmonary disease: a new algorithm for pre-flight evaluation. Thorax. 2012 Nov;67(11):964-9. doi: 10.1136/thoraxjnl-2012-201855. Epub 2012 Jul 5.
PubMed 22767877Edvardsen A, Akero A, Hardie JA, Ryg M, Eagan TM, Skjonsberg OH, Bakke PS. High prevalence of respiratory symptoms during air travel in patients with COPD. Respir Med. 2011 Jan;105(1):50-6. doi: 10.1016/j.rmed.2010.10.006. Epub 2010 Oct 25.
PubMed 20974527Howard LS. Last call for the flight simulation test? Eur Respir J. 2013 Nov;42(5):1175-7. doi: 10.1183/09031936.00037813. No abstract available.
PubMed 24178931Ahmedzai S, Balfour-Lynn IM, Bewick T, Buchdahl R, Coker RK, Cummin AR, Gradwell DP, Howard L, Innes JA, Johnson AO, Lim E, Lim WS, McKinlay KP, Partridge MR, Popplestone M, Pozniak A, Robson A, Shovlin CL, Shrikrishna D, Simonds A, Tait P, Thomas M; British Thoracic Society Standards of Care Committee. Managing passengers with stable respiratory disease planning air travel: British Thoracic Society recommendations. Thorax. 2011 Sep;66 Suppl 1:i1-30. doi: 10.1136/thoraxjnl-2011-200295. No abstract available.
PubMed 21856702
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoxia in Flight Simulation in Obese Patients
- ClinicalTrials.gov ID
- NCT02636465
- Acronym / sponsor ID
- WI_105/2013
- Conditions
- Obesity, COPD, OHS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.VUniversity, hospital or other
- Collaborators
- Deutsche Luft und Raumfahrt
- Study start
- Mar 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 Dec 2015 (estimated)
- 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 pilot study is to determine whether obese adults,obese (BMI>30 kg/m2) with obesity hypoventilation or obese COPD-patients do undergo oxygen desaturation under flight simulation and if the hypoxic altitude simulation test is as effective as the hypoxic chamber test.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| obese healthy adults | – | Other: flight simulationin obese healthy adults or obese patients with or without COPD, OHSpersons with BMI> 30 kg/m2 |
| obese COPD patients | – | Other: flight simulationin obese healthy adults or obese patients with or without COPD, OHSCOPD-patients (GOLD I-IV Group A-D) with BMI> 30 kg/m2 |
| OHS-patients | – | Other: flight simulationin obese healthy adults or obese patients with or without COPD, OHSpatients with defined OHS: BMI>30 kg/m2 and sleep related breathing disease, no COPD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- obese (BMI>30 kg/m2) healthy adults, obese patients with obesity hypoventilation Syndrome, obese patients with COPD
Key inclusion criteria (3 listed)
- age ≥ 18 years
- patients with COPD (GOLD I-IV Group A-D) with obesity (BMI> 30kg/m2), obese healthy adults with BMI> 30kg /m2, patients with Obesity hypoventilation syndrome
- informed consent provided
Key exclusion criteria (5 listed)
- patients less than BMI <30 kg/m2 with or without COPD, OHS
- Age < 18 years
- pregnancy, lactation
- any medical, psychological or other condition restricting the patient's ability to provide informed consent
- participation in another clinical trial
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 |
|---|---|---|
| flight simulationin obese healthy adults or obese patients with or without COPD, OHSAlso: flight simulation | Other | OHS-patients, obese COPD patients, obese healthy adults |
Primary outcome
desaturation (SaO2 in %) in flight simulation in obese patients
Time frame: one hour each patient
1 secondary outcome
desaturation (SaO2 in %) in hypoxic chamber test versus hypoxia altitude Simulation test
Time frame: one hour each patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2015.
- Background: PubMed 23258777Edvardsen A, Ryg M, Akero A, Christensen CC, Skjonsberg OH. COPD and air travel: does hypoxia-altitude simulation testing predict in-flight respiratory symptoms? Eur Respir J. 2013 Nov;42(5):1216-23. doi: 10.1183/09031936.00157112. Epub 2012 Dec 20.
- Background: PubMed 22767877Edvardsen A, Akero A, Christensen CC, Ryg M, Skjonsberg OH. Air travel and chronic obstructive pulmonary disease: a new algorithm for pre-flight evaluation. Thorax. 2012 Nov;67(11):964-9. doi: 10.1136/thoraxjnl-2012-201855. Epub 2012 Jul 5.
- Background: PubMed 20974527Edvardsen A, Akero A, Hardie JA, Ryg M, Eagan TM, Skjonsberg OH, Bakke PS. High prevalence of respiratory symptoms during air travel in patients with COPD. Respir Med. 2011 Jan;105(1):50-6. doi: 10.1016/j.rmed.2010.10.006. Epub 2010 Oct 25.
- Background: PubMed 24178931Howard LS. Last call for the flight simulation test? Eur Respir J. 2013 Nov;42(5):1175-7. doi: 10.1183/09031936.00037813. No abstract available.
- Background: PubMed 21856702Ahmedzai S, Balfour-Lynn IM, Bewick T, Buchdahl R, Coker RK, Cummin AR, Gradwell DP, Howard L, Innes JA, Johnson AO, Lim E, Lim WS, McKinlay KP, Partridge MR, Popplestone M, Pozniak A, Robson A, Shovlin CL, Shrikrishna D, Simonds A, Tait P, Thomas M; British Thoracic Society Standards of Care Committee. Managing passengers with stable respiratory disease planning air travel: British Thoracic Society recommendations. Thorax. 2011 Sep;66 Suppl 1:i1-30. doi: 10.1136/thoraxjnl-2011-200295. No abstract available.
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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?
An observational study of Obesity, COPD, OHS, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.
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 5 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: finished, as of the sponsor's last update on 21 Dec 2015. 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 Germany. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
desaturation (SaO2 in %) in flight simulation in obese patients (time frame: one hour each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02636465, which also lists 5 linked publications.
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 21 Dec 2015.