Effects of Acute Intermittent Hypoxia on Sensory Function in Healthy Adults

Sensitivity Clinical Trial

— SensoryFLO  

Official title:

Effects of Acute Intermittent Hypoxia on Sensory Function in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03283072
• Other study ID #: IRB201700637
• Status: Completed
• Phase: N/A
• Start date: September 18, 2017
• Est. completion date: July 6, 2020

Study information

• Verified date: August 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 6, 2020
• Est. primary completion date: July 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypoxia
• Sensitivity

Intervention

Device:
• 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 4 (sham)
15 bouts of 1min:1min normoxia

Locations

Country	Name	City	State
United States	Unversity of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensory Function	Thermal thresholds. Average reported.	Every 10 minutes for 60 minutes post intervention, average reported
Primary	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
Primary	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