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Saline + Fentanyl for Shortness of Breath in Hypoxic Exercise
N/A
Waitlist Available
Led By Philip N Ainslie, PhD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
no history of cardiovascular, respiratory or neurological disease
aged 19 - 40 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the duration, i.e., however long it takes to complete the exercise; this is typically 7-14 minutes
Awards & highlights
Study Summary
This trial will compare muscle reflex response in normal, brief- and long-term low-oxygen conditions.
Who is the study for?
This trial is for healthy individuals aged 19-40 who are part of the high altitude expedition to White Mountain in 2023. They should not be on any medication except oral contraception and must have no history of heart, lung, or brain diseases. Pregnant or post-menopausal individuals, obese persons, smokers, and those on exercise-affecting prescriptions cannot participate.Check my eligibility
What is being tested?
The study tests how muscle reflexes respond to different oxygen levels during cycling exercises. Participants will undergo light-to-high intensity cycling with their muscle reflex either suppressed by Fentanyl or unaffected (saline control). This will happen at sea level and after living two weeks at high altitude to assess changes under acute and chronic hypoxia.See study design
What are the potential side effects?
Fentanyl may cause side effects such as drowsiness, nausea, itching, sweating, dry mouth and slowed breathing. Saline is generally safe but can sometimes lead to minor reactions like irritation at the injection site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have no history of heart, lung, or brain diseases.
Select...
I am between 19 and 40 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ data collected during steady-state breathing in the last minute of exercise
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~data collected during steady-state breathing in the last minute of exercise
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Continuous Positive Airway Pressure
Secondary outcome measures
Mean arterial blood pressure (entire pressure wave)
Other outcome measures
Exercise performance
Side effects data
From 2009 Phase 4 trial • 237 Patients • NCT01795898100%
Aneurysm ruptured
54%
Dizziness
39%
Nausea
26%
Vomiting
16%
Somnolence
5%
Pruritus
2%
Insomnia
2%
Headache
1%
Weakness
1%
Palpitation
1%
Rashes
1%
Chest pain
1%
Cold clammy perspiration
1%
Flushing
1%
Muscle trembling
1%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fentanyl
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Sea level experimental (muscle reflex suppression)Experimental Treatment1 Intervention
Sea level exercise will be completed after the administration of 0.25 mL of fentanyl into the intrathecal (spinal) space between L3-L4.
Group II: High altitude experimental (muscle reflex suppression)Experimental Treatment1 Intervention
High altitude exercise will be completed after the administration of 0.25 mL of fentanyl into the intrathecal (spinal) space between L3-L4.
Group III: Sea level controlPlacebo Group1 Intervention
Sea level exercise will be completed after the administration of 1 mL of isotonic saline into the intrathecal (spinal) space between L3-L4.
Group IV: High altitude controlPlacebo Group1 Intervention
High altitude exercise will be completed after the administration of 1 mL of isotonic saline into the intrathecal (spinal) space between L3-L4.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fentanyl
2019
Completed Phase 4
~1870
Find a Location
Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,415 Previous Clinical Trials
2,467,002 Total Patients Enrolled
Philip N Ainslie, PhDPrincipal InvestigatorUniversity of British Columbia- Okanagan
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are very overweight.You currently smoke cigarettes.People who are planning to go on a high-altitude expedition to White Mountain in 2023.I am on medication that could change how I respond to physical activity.I am not on any medications except for oral contraceptives.I have no history of heart, lung, or brain diseases.I am between 19 and 40 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Sea level control
- Group 2: High altitude control
- Group 3: Sea level experimental (muscle reflex suppression)
- Group 4: High altitude experimental (muscle reflex suppression)
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 0 awards, including:Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research encompass individuals aged 70 and beyond?
"For this clinical trial, only individuals between the ages of 19 and 40 are eligible for enrollment. Separately, there 41 trials available to those under 18 years old and 146 studies intended specifically for participants over 65."
Answered by AI
Are there any ongoing recruitment efforts for this experiment?
"Per the information on clinicaltrials.gov, this investigation is not presently enrolling participants; it was initially publicized on June 1st 2023 and most recently updated November 9th 2022. However, at present there are 209 alternative studies that require volunteers to take part in them."
Answered by AI
Do I meet the requirements to partake in this research trial?
"Eligible applicants for this research must be aged 19 to 40 years old, not taking any medication unless it is oral contraception, free of cardiovascular, respiratory or neurological sicknesses and members of the White Mountain expedition set to take place in 2023. A total of 14 people with dyspnea can participate."
Answered by AI
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