NCT03283072: SensoryFLO

Effects of Acute Intermittent Hypoxia on Sensory Function in Healthy Adults

Completed NA Results posted Last updated 21 August 2023

What this trial tests

NA trial testing Intervention 1 in Sensitivity in 22 participants. Completed in 6 July 2020.

Timeline

18 September 2017

Primary endpoint
6 July 2020

6 July 2020

Quick facts

Lead sponsor	University of Florida
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	other
Enrollment	22
Start date	18 September 2017
Primary completion	6 July 2020
Estimated completion	6 July 2020
Sites	1 location across United States

Drugs / interventions tested

• Intervention 1 — full drug profile →
• Intervention 2 — full drug profile →
• Intervention 3
• Intervention 4 (sham)

Conditions studied

• Sensitivity — all drugs for Sensitivity →

Sponsor

University of Florida

Who can join

Adults 18 to 40, any sex, with Sensitivity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Sensory Function Primary · Every 10 minutes for 60 minutes post intervention, average reported

Thermal thresholds. Average reported.

Group	Value	95% CI
Intervention 1	46.7	± 1.5
Intervention 2	46.4	± 1.9
Intervention 3	46.1	± 1.9
Intervention 4 (Sham)	45.9	± 2.1

Temporal Sensory Summation Primary · Every 10 minutes for 60 minutes post intervention, average reported

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.

Group	Value	95% CI
Intervention 1	17.4	± 13.3
Intervention 2	11.7	± 10.2
Intervention 3	10.9	± 11.2
Intervention 4 (Sham)	11.9	± 15.6

Sensory Function - Pressure Primary · Every 10 minutes for 60 minutes post intervention, average reported

Pressure threshold is the force at which the sensation of pressure first is considered painful by the participant, average reported

Group	Value	95% CI
Intervention 1	4.4	± 3.4
Intervention 2	4.6	± 2.5
Intervention 3	4.3	± 2.8
Intervention 4 (Sham)	4.3	± 3.1

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.