Back to resultsEffects of Acute Intermittent Hypoxia on Sensory Function in Healthy Adults (SensoryFLO)
Primary Purpose
Sensitivity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention 1
Intervention 2
Intervention 3
Intervention 4 (sham)
Sponsored by
About this trial
This is an interventional other trial for Sensitivity focused on measuring thermal threshold, pressure pain threshold, temporal summation
Eligibility Criteria
Inclusion Criteria:
- 18 to 40 years of age
Exclusion Criteria:
- Diagnosis of cardiovascular disease (Hypertension, arrhythmias, coronary artery disease, congenital and valvar heart diseases)
- Diagnosis of neuromuscular disease
- Diagnosis of any neurological disease
- Presence of concurrent medical illness including infection, fractures
- Diagnosis of obstructive sleep apnea
- Diagnosis of obstructive/restrictive lung disease
- Diagnosis of exercise induced asthma
- FEV1/FVC<80% and/or FVC<80% of predicted value indicating airway obstruction
- Subjects on prednisolone therapy or selective serotonin reuptake inhibitor (SSRI) therapy will be excluded from the study as these pharmacological agents are known to amplify the effects of IH[22, 23]
- Diagnosis of epilepsy or history of seizures and attention deficit disorders
- Pregnancy
- Diabetes
- History of coagulation disorders
- History of chronic pain
- Body mass index(BMI)> 35kg/m2
- Subjects on prescription medicines such as beta blockers and other drugs that are prescribed in any of the exclusionary disorders listed above.
Sites / Locations
- Unversity of Florida
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Sequence 1
Sequence 2
Sequence 3
Sequence 4
Arm Description
Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia (sham)
Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia (sham) Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia
Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia (sham) Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia
15 bouts of 1min:1min normoxia (sham) Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia
Outcomes
Primary Outcome Measures
Sensory Function
Thermal thresholds. Average reported.
Temporal Sensory Summation
Temporal summation represents increases in ratings of pain intensity measured using a numeric pain rating scale (0-no pain to 100-worst pain imaginable) to repeated heat stimuli of the same intensity; that is, "summation" represents increases in participant ratings of pain despite the maintenance of a standard temperature and is calculated as the difference between pain rating 1 and pain rating 6. Positive difference scores indicate that pain reported increased over the 6 pulses of heat. Here, the average difference across participants and over time is reported.
Sensory Function - Pressure
Pressure threshold is the force at which the sensation of pressure first is considered painful by the participant, average reported
Secondary Outcome Measures
Full Information
NCT ID
NCT03283072
First Posted
September 7, 2017
Last Updated
August 18, 2023
Sponsor
University of Florida
1. Study Identification
Unique Protocol Identification Number
NCT03283072
Brief Title
Effects of Acute Intermittent Hypoxia on Sensory Function in Healthy Adults
Acronym
SensoryFLO
Official Title
Effects of Acute Intermittent Hypoxia on Sensory Function in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 18, 2017 (Actual)
Primary Completion Date
July 6, 2020 (Actual)
Study Completion Date
July 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Exposure to acute intermittent hypoxia (AIH) can facilitate of motor output but no studies of sensory effects has been reported.
Detailed Description
Despite the strong results of motor studies, the affects of AIH on sensory function has not been established. We will use a commercially-available hypoxicator that can be programmed to achieve a targeted level of arterial oxygen saturation. We plan to compare 3 previously published protocols that have generated motor facilitation (and a sham condition) to characterize and effects on sensory function in healthy adults.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensitivity
Keywords
thermal threshold, pressure pain threshold, temporal summation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Within subjects design with randomization of presentation of four different hypoxia/normoxia intervals.
Masking
ParticipantOutcomes Assessor
Masking Description
Participants can't see the device and therefore the settings. The assessment of sensory function is done by a separate investigator who did not participate in the set up of the hypoxicator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia (sham)
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia (sham) Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia
Arm Title
Sequence 3
Arm Type
Experimental
Arm Description
Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia (sham) Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia
Arm Title
Sequence 4
Arm Type
Experimental
Arm Description
15 bouts of 1min:1min normoxia (sham) Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia
Intervention Type
Device
Intervention Name(s)
Intervention 1
Intervention Description
15 bouts of 2mins:1min hypoxia:hyperoxia
Intervention Type
Device
Intervention Name(s)
Intervention 2
Intervention Description
15 bouts of 1mins:1min hypoxia:hyperoxia
Intervention Type
Device
Intervention Name(s)
Intervention 3
Intervention Description
8 bouts of 2mins:1min hypoxia:hyperoxia
Intervention Type
Device
Intervention Name(s)
Intervention 4 (sham)
Intervention Description
15 bouts of 1min:1min normoxia
Primary Outcome Measure Information:
Title
Sensory Function
Description
Thermal thresholds. Average reported.
Time Frame
Every 10 minutes for 60 minutes post intervention, average reported
Title
Temporal Sensory Summation
Description
Temporal summation represents increases in ratings of pain intensity measured using a numeric pain rating scale (0-no pain to 100-worst pain imaginable) to repeated heat stimuli of the same intensity; that is, "summation" represents increases in participant ratings of pain despite the maintenance of a standard temperature and is calculated as the difference between pain rating 1 and pain rating 6. Positive difference scores indicate that pain reported increased over the 6 pulses of heat. Here, the average difference across participants and over time is reported.
Time Frame
Every 10 minutes for 60 minutes post intervention, average reported
Title
Sensory Function - Pressure
Description
Pressure threshold is the force at which the sensation of pressure first is considered painful by the participant, average reported
Time Frame
Every 10 minutes for 60 minutes post intervention, average reported
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 to 40 years of age
Exclusion Criteria:
Diagnosis of cardiovascular disease (Hypertension, arrhythmias, coronary artery disease, congenital and valvar heart diseases)
Diagnosis of neuromuscular disease
Diagnosis of any neurological disease
Presence of concurrent medical illness including infection, fractures
Diagnosis of obstructive sleep apnea
Diagnosis of obstructive/restrictive lung disease
Diagnosis of exercise induced asthma
FEV1/FVC<80% and/or FVC<80% of predicted value indicating airway obstruction
Subjects on prednisolone therapy or selective serotonin reuptake inhibitor (SSRI) therapy will be excluded from the study as these pharmacological agents are known to amplify the effects of IH[22, 23]
Diagnosis of epilepsy or history of seizures and attention deficit disorders
Pregnancy
Diabetes
History of coagulation disorders
History of chronic pain
Body mass index(BMI)> 35kg/m2
Subjects on prescription medicines such as beta blockers and other drugs that are prescribed in any of the exclusionary disorders listed above.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark D Bishop, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unversity of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Acute Intermittent Hypoxia on Sensory Function in Healthy Adults
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