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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 below
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I have no history of heart, lung, or brain diseases.
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I am between 19 and 40 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~data collected during steady-state breathing in the last minute of exercise
This trial's timeline: 3 weeks for screening, Varies for treatment, and data collected during steady-state breathing in the last minute of exercise for reporting.

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 • NCT01795898
100%
Aneurysm ruptured
54%
Dizziness
39%
Nausea
26%
Vomiting
16%
Somnolence
5%
Pruritus
2%
Headache
2%
Insomnia
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
~1850

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,422 Previous Clinical Trials
2,468,246 Total Patients Enrolled
Philip N Ainslie, PhDPrincipal InvestigatorUniversity of British Columbia- Okanagan

Media Library

Sea level experimental (muscle reflex suppression) Clinical Trial Eligibility Overview. Trial Name: NCT05619887 — N/A
Muscle strain Research Study Groups: Sea level control, High altitude control, Sea level experimental (muscle reflex suppression), High altitude experimental (muscle reflex suppression)
Sea level experimental (muscle reflex suppression) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05619887 — N/A
Muscle strain Clinical Trial 2023: Sea level experimental (muscle reflex suppression) Highlights & Side Effects. Trial Name: NCT05619887 — N/A
~7 spots leftby Jun 2025
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