HealthyPhase 1SPACE-COTNCT02493985
Studying Physiological and Anatomical Cerebral Effects of Carbon Dioxide and Tilt
A Phase 1 study testing 0.5% CO2 and ambient air in people with Healthy, run by Baylor College of Medicine.
Trial summary
The purpose of this study is to study the effects of carbon dioxide combined with head down tilt on cerebral physiology and anatomy. This paradigm will help establish a ground-based analog for spaceflight, and also evaluate the ability of non-invasive devices to monitor brain physiology. Read more about this study
- Who is it for?
- Ages 30 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 0.5% CO2 and ambient air
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jul 2015
- Phase
- Phase 1
- 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 30 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Ages between 30 to 55 years old
- Body Mass Index (BMI) of 20-26 kg/m2
- Weight between 65-85 kg
- Height between 158-190 cm
- Non-smoker, for at least six months before the start of the study
- VO2 max of at least 30ml/kg/min
Who cannot join
- History of intracranial pressure elevation
- History of abnormal intraocular pressure
- Ophthalmological conditions: glaucoma, retinopathy, severe cataracts, eye trauma or implants.
- History of diseases of the optic nerve
- Pre-existing corneal injury
- History of these eye surgeries: implanted lens, corneal transplant, recent (less than 6 months) LASIK surgery
Show all 57Show fewer
- Congenital abnormalities of the anterior chamber
- Active eye infections, recent corneal abrasions, inflammation
- Intraocular pressure greater than 20 mm Hg
- Viral or bacterial eye infection Severe dry eye syndrome
- Retinal or choroidal detachment
- More than -6,0 dpr (high myopia)
- More than +5,0 dpr
- Arm or shoulder injury in the past year
- Psychiatric conditions including major depression, bipolar disorder or severe anxiety
- History of cerebrovascular disease including brain aneurysms, stroke, transient ischemic attack, brain hemorrhage, arteriovenous malformations History of brain tumor, congenital cysts, hydrocephalus, brain injury (requiring hospitalization)
- Meningitis/encephalitis
- Epilepsy
- History of severe hypertension (> 160/90 mmHg),
- Diabetes mellitus
- Coronary artery disease
- Congestive heart failure
- Ventricular or atrial arrhythmias
- Autonomic disorders (syncope, autoimmune neuropathy)
- Hepatic disease
- Renal disease
- Chronic infections including HIV, Hepatitis B or C, Lyme disease
- History of hematological disease including hemophilia, leukemia, thrombocytosis, thrombocytopenia, myelodysplastic syndrome, autoimmune disease (lupus, rheumatoid arthritis, Sjogren's syndrome)
- History of malignancy except for basal cell carcinoma
- Chronic back pain (inability to lay in bed for long periods of time)
- Conditions that would preclude MRI including severe claustrophobia, pace maker or other metallic implants or devices
- Sleep disturbances including: obstructive sleep apnea, narcolepsy, insomnia - Medications that exert cardiovascular, cerebrovascular or psychiatric function (i.e. beta blockers, calcium channel blockers, diuretics, diamox, sedatives) Drug, medication or alcohol abuse (regular consumption of more than 20-30 g alcohol/day)*
- Smoking
- VO2 max less than 30 ml/kg/min or greater than 60 ml/kg/min
- Vegetarian, vegan
- Migraine
- Previous psychiatric illness
- Hiatus hernia
- Gastro-esophageal reflux
- Diabetes mellitus
- Rheumatic illness
- Muscle or joint disorder
- Pronounced orthostatic intolerance (< 10 min standing)
- Hyperlipidaemia
- Thyroid gland disorder: deviations from normal values for TSH in plasma
- Hyper-homocysteinaemia
- Hyperuricaemia or hypouricaemia: deviations from normal values for uric acid in plasma.
- Hypercalcaemia or hypocalcaemia: deviations from normal values for calcium in plasma.
- Iron deficiency
- Vitamin D deficiency
- Baseline blood gas values deviating from the normal reference values
- Elevated risk of venous thromboembolism including deep venous thrombosis, pulmonary embolism
- Chronic back complaints
- Participation in another clinical study within the last 3 months before start of this study
- Criminal record
- Stomach sleepers
- Any other medical condition that the investigators consider a contraindication to the study procedures that would make it unsafe or confound the measurements.
About this study
The purpose of this study is to study the effects of carbon dioxide combined with head down tilt on cerebral physiology and anatomy. This paradigm will help establish a ground-based analog for spaceflight, and also evaluate the ability of non-invasive devices to monitor brain physiology.
Read the detailed description
Many of the long duration astronauts develop visual changes, associated with neuroophthalmological abnormalities suggesting elevated intracranial pressure. There is currently no suitable ground based analog to simulate these changes on Earth, or a standard methodological approach to monitoring the combined effects of head down tilt and atmospheric carbon dioxide. Given that carbon dioxide and cephalad fluid shifting are known factors in spaceflight, we sought to evaluate an approach to monitoring these effects in healthy subject in a ground based analog on Earth.
- Conditions
- Healthy
- Being tested
- 0.5% CO2, ambient air
- Keywords
- Brain physiology, Intracranial pressure, Cognition, Cerebrovascular, Head down tilt, Space flight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% CO2Other
The subjects will be randomized to breath 0.5% carbon dioxide during one of the -12 degree head down tilt body position periods in crossover design
ambient airOther
The subjects will be randomized to breath ambient air during one of the -12 degree head down tilt body position periods in crossover design
| Study group | Role | What they receive |
|---|---|---|
| Atmosphere 1 - Ambient air | Active comparator | First, the subjects will have 1 baseline day in the upright body position. This will be followed by 28 hours of head down tilt body position and ambient air at sea level, followed by 2 hour exposure of 3% carbon dioxide inhalation. Receives: Other: ambient air |
| Atmosphere 2 - 0.5% CO2 | Experimental | First, the subjects will have 1 baseline day in the upright body position. This will be followed by 28 hours of head down tilt body position and air with 0.5% carbon dioxide, followed by 2 hour exposure of 3% carbon dioxide inhalation. Receives: Other: 0.5% CO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cerebral blood flow: Transcranial doppler
Transcranial Doppler derived measurements of mean cerebral blood flow velocity
Measured: 24 and 48 hours from baseline measurements
Changes in intracranial volume
Cerebrotech monitor derived intracranial fluid volume changes (percentage change)
Measured: 24 and 48 hours from baseline measurements
Changes in intracranial pressure
Vittamed ICP meter derived intracranial pressure (mmHg)
Measured: 24 and 48 hours from baseline measurements
Changes in cognitive function
Cognition battery score (max 1000): tests multiple cognitive domains including spatial memory, psychomotor processing speed, facial emotional recognition
Measured: 24 and 48 hours from baseline measurements
Changes in cerebral blood flow: cFLOW
cFLOW derived changes in cerebral blood flow index
Measured: 24 and 48 hours from baseline measurements
Secondary outcomes (8)
Tolerability of combined -12 head down tilt and 0.5% carbon dioxide
Assess safety outcomes: tolerance of condition through duration of study and number of adverse events
Measured: Within 48 hours from baseline
Changes in intraocular pressure
iCare derived intraocular pressure measurements from both eyes (mmHg)
Measured: 24 and 48 hours from baseline measurements
Changes in pulmonary mechanics
minute ventilation, respiratory rate and vital capacity
Measured: 24 and 48 hours from baseline measurements
Changes in internal jugular vein volumes
Ultrasound derived measure of right internal jugular vein cross sectional areas
Measured: 48 hours from baseline measurements
Changes in peripheral arterial vasoreactivity
Ultrasound Doppler Measurement of arterial diameter and flow (cm/sec) after transient cuff occlusion of brachial artery
Measured: 48 hours from baseline measurements
Changes in cardiac hemodynamics
Assessment of cardiac output, stroke volume, heart rate, blood pressure
Measured: 48 hours from baseline measurements
Changes in olfactory threshold
Sniffin' sticks threshold testing for phenyethyl alcohol
Measured: 24 and 48 hours from baseline measurement
Changes in pulmonary gas exchange
changes in arterial pH and partial pressure CO2
Measured: 24 and 48 hours from baseline measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Space Biomedical Research Institute, DLR German Aerospace Center, The University of Texas Health Science Center, Houston, University of Pennsylvania, Harvard University, University of Cologne
- Responsible party
- Principal investigator, Eric Michael Bershad, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493985
- Sponsor's protocol ID
- H-36485
- Acronym
- SPACE-COT
- Status last verified
- Jan 2016
- First submitted
- 27 Jun 2015
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying Physiological and Anatomical Cerebral Effects of Carbon Dioxide and Tilt
- ClinicalTrials.gov ID
- NCT02493985
- Acronym / sponsor ID
- SPACE-COT / H-36485
- Conditions
- Healthy
- Keywords
- Brain physiology, Intracranial pressure, Cognition, Cerebrovascular, Head down tilt, Space flight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Space Biomedical Research Institute, DLR German Aerospace Center, The University of Texas Health Science Center, Houston, University of Pennsylvania, Harvard University, University of Cologne
- Study start
- Jun 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Jul 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 study is to study the effects of carbon dioxide combined with head down tilt on cerebral physiology and anatomy. This paradigm will help establish a ground-based analog for spaceflight, and also evaluate the ability of non-invasive devices to monitor brain physiology.
Detailed description
Many of the long duration astronauts develop visual changes, associated with neuroophthalmological abnormalities suggesting elevated intracranial pressure. There is currently no suitable ground based analog to simulate these changes on Earth, or a standard methodological approach to monitoring the combined effects of head down tilt and atmospheric carbon dioxide. Given that carbon dioxide and cephalad fluid shifting are known factors in spaceflight, we sought to evaluate an approach to monitoring these effects in healthy subject in a ground based analog on Earth.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atmosphere 1 - Ambient air | Active comparator | Other: ambient airFirst, the subjects will have 1 baseline day in the upright body position. This will be followed by 28 hours of head down tilt body position and ambient air at sea level, followed by 2 hour exposure of 3% carbon dioxide inhalation. |
| Atmosphere 2 - 0.5% CO2 | Experimental | Other: 0.5% CO2First, the subjects will have 1 baseline day in the upright body position. This will be followed by 28 hours of head down tilt body position and air with 0.5% carbon dioxide, followed by 2 hour exposure of 3% carbon dioxide inhalation. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male
- Ages between 30 to 55 years old
- Body Mass Index (BMI) of 20-26 kg/m2
- Weight between 65-85 kg
- Height between 158-190 cm
Key exclusion criteria (57 listed)
- History of intracranial pressure elevation
- History of abnormal intraocular pressure
- Ophthalmological conditions: glaucoma, retinopathy, severe cataracts, eye trauma or implants.
- History of diseases of the optic nerve
- Pre-existing corneal injury
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 |
|---|---|---|
| 0.5% CO2The subjects will be randomized to breath 0.5% carbon dioxide during one of the -12 degree head down tilt body position periods in crossover design | Other | Atmosphere 2 - 0.5% CO2 |
| ambient airThe subjects will be randomized to breath ambient air during one of the -12 degree head down tilt body position periods in crossover design | Other | Atmosphere 1 - Ambient air |
Primary outcome
Changes in cerebral blood flow: Transcranial doppler
Time frame: 24 and 48 hours from baseline measurements
Transcranial Doppler derived measurements of mean cerebral blood flow velocity
Changes in intracranial volume
Time frame: 24 and 48 hours from baseline measurements
Cerebrotech monitor derived intracranial fluid volume changes (percentage change)
Changes in intracranial pressure
Time frame: 24 and 48 hours from baseline measurements
Vittamed ICP meter derived intracranial pressure (mmHg)
Changes in cognitive function
Time frame: 24 and 48 hours from baseline measurements
Cognition battery score (max 1000): tests multiple cognitive domains including spatial memory, psychomotor processing speed, facial emotional recognition
Changes in cerebral blood flow: cFLOW
Time frame: 24 and 48 hours from baseline measurements
cFLOW derived changes in cerebral blood flow index
8 secondary outcomes
Tolerability of combined -12 head down tilt and 0.5% carbon dioxide
Time frame: Within 48 hours from baseline
Changes in intraocular pressure
Time frame: 24 and 48 hours from baseline measurements
Changes in pulmonary mechanics
Time frame: 24 and 48 hours from baseline measurements
Changes in internal jugular vein volumes
Time frame: 48 hours from baseline measurements
Changes in peripheral arterial vasoreactivity
Time frame: 48 hours from baseline measurements
Changes in cardiac hemodynamics
Time frame: 48 hours from baseline measurements
Changes in olfactory threshold
Time frame: 24 and 48 hours from baseline measurement
Changes in pulmonary gas exchange
Time frame: 24 and 48 hours from baseline measurements
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 13 Jan 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 0.5% CO2 and ambient air in people with Healthy, run by Baylor College of Medicine.
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 7 inclusion and 57 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 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in cerebral blood flow: Transcranial doppler (time frame: 24 and 48 hours from baseline measurements). The study lists 5 primary outcomes in all. 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 13 Jan 2016.