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

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

Study Overview

• Status: Completed
• Conditions: Sensitivity
• Intervention / Treatment: Device: Intervention 1; Device: Intervention 2; Device: Intervention 3; Device: Intervention 4 (sham)

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
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • Unversity of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; 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)	Device: Intervention 1; 15 bouts of 2mins:1min hypoxia:hyperoxia; Device: Intervention 2; 15 bouts of 1mins:1min hypoxia:hyperoxia; Device: Intervention 3; 8 bouts of 2mins:1min hypoxia:hyperoxia; Device: Intervention 4 (sham); 15 bouts of 1min:1min normoxia
Experimental: Sequence 2; 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	Device: Intervention 1; 15 bouts of 2mins:1min hypoxia:hyperoxia; Device: Intervention 2; 15 bouts of 1mins:1min hypoxia:hyperoxia; Device: Intervention 3; 8 bouts of 2mins:1min hypoxia:hyperoxia; Device: Intervention 4 (sham); 15 bouts of 1min:1min normoxia
Experimental: Sequence 3; 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	Device: Intervention 1; 15 bouts of 2mins:1min hypoxia:hyperoxia; Device: Intervention 2; 15 bouts of 1mins:1min hypoxia:hyperoxia; Device: Intervention 3; 8 bouts of 2mins:1min hypoxia:hyperoxia; Device: Intervention 4 (sham); 15 bouts of 1min:1min normoxia
Experimental: Sequence 4; 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	Device: Intervention 1; 15 bouts of 2mins:1min hypoxia:hyperoxia; Device: Intervention 2; 15 bouts of 1mins:1min hypoxia:hyperoxia; Device: Intervention 3; 8 bouts of 2mins:1min hypoxia:hyperoxia; Device: Intervention 4 (sham); 15 bouts of 1min:1min normoxia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory Function	Thermal thresholds. Average reported.	Every 10 minutes for 60 minutes post intervention, 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.	Every 10 minutes for 60 minutes post intervention, average reported
Sensory Function - Pressure	Pressure threshold is the force at which the sensation of pressure first is considered painful by the participant, average reported	Every 10 minutes for 60 minutes post intervention, average reported

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Mark D Bishop, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2017
• Primary Completion (Actual): July 6, 2020
• Study Completion (Actual): July 6, 2020

Study Registration Dates

• First Submitted: September 7, 2017
• First Submitted That Met QC Criteria: September 13, 2017
• First Posted (Actual): September 14, 2017

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: pressure pain threshold; thermal threshold; temporal summation
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: IRB201700637

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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