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Effects of Acute Intermittent Hypoxia on Sensory Function in Healthy Adults (SensoryFLO)

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ClinicalTrials.gov Identifier: NCT03283072
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
Exposure to acute intermittent hypoxia (AIH) can facilitate of motor output but no studies of sensory effects has been reported.

Condition or disease Intervention/treatment Phase
Sensitivity Device: Hypoxicator Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: within subjects design with randomization of presentation of the different hypoxia/normoxia intervals.
Masking: Triple (Participant, Investigator, Outcomes 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
Primary Purpose: Other
Official Title: Effects of Acute Intermittent Hypoxia on Sensory Function in Healthy Adults
Actual Study Start Date : September 18, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Arm Intervention/treatment
Sham Comparator: Sham
normoxia for 2 minutes, normoxia 1 minute x 8 using hypoxicator
Device: Hypoxicator
Repeated bouts of hypoxia/normoxia

Experimental: Trubower
15 bouts of hypoxia for 1 minute, normoxic 1 minute using hypoxicator
Device: Hypoxicator
Repeated bouts of hypoxia/normoxia

Experimental: Hayes
15 bouts of hypoxia for 2 minutes, normoxic 1 minute using hypoxicator
Device: Hypoxicator
Repeated bouts of hypoxia/normoxia

Experimental: Tester
8 bouts of hypoxia for 2 minutes, normoxic 1 minute using hypoxicator
Device: Hypoxicator
Repeated bouts of hypoxia/normoxia




Primary Outcome Measures :
  1. Sensory function [ Time Frame: Every 10 minutes for 60 minutes post intervention ]
    sensory thresholds

  2. Pain sensitivity [ Time Frame: Every 10 minutes for 60 minutes post intervention ]
    temporal sensory summation



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 to 40 years of age

Exclusion Criteria:

  1. Diagnosis of cardiovascular disease (Hypertension, arrhythmias, coronary artery disease, congenital and valvar heart diseases)
  2. Diagnosis of neuromuscular disease
  3. Diagnosis of any neurological disease
  4. Presence of concurrent medical illness including infection, fractures
  5. Diagnosis of obstructive sleep apnea
  6. Diagnosis of obstructive/restrictive lung disease
  7. Diagnosis of exercise induced asthma
  8. FEV1/FVC<80% and/or FVC<80% of predicted value indicating airway obstruction
  9. 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]
  10. Diagnosis of epilepsy or history of seizures and attention deficit disorders
  11. Pregnancy
  12. Diabetes
  13. History of coagulation disorders
  14. History of chronic pain
  15. Body mass index(BMI)> 35kg/m2
  16. Subjects on prescription medicines such as beta blockers and other drugs that are prescribed in any of the exclusionary disorders listed above.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283072


Contacts
Contact: Mark D Bishop, PhD 352-2736112 sensoryFLO@gmail.com

Locations
United States, Florida
Unversity of Florida Recruiting
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Mark D Bishop, PhD University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03283072     History of Changes
Other Study ID Numbers: IRB201700637
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Florida:
thermal threshold
pressure pain threshold
temporal summation

Additional relevant MeSH terms:
Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms