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

University of Florida

Status: Completed

Conditions: Sensitivity

Treatments: Device: Intervention 1; Device: Intervention 4 (sham); Device: Intervention 2; Device: Intervention 3

Study type: Interventional

Funder types: Other

Identifiers

NCT03283072

IRB201700637

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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22 participants in 4 patient groups

Sequence 1

Experimental group

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)

Treatment:

Device: Intervention 4 (sham)

Device: Intervention 3

Device: Intervention 2

Device: Intervention 1

Sequence 2

Experimental group

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

Treatment:

Device: Intervention 4 (sham)

Device: Intervention 3

Device: Intervention 2

Device: Intervention 1

Sequence 3

Experimental group

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

Treatment:

Device: Intervention 4 (sham)

Device: Intervention 3

Device: Intervention 2

Device: Intervention 1

Sequence 4

Experimental group

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

Treatment:

Device: Intervention 4 (sham)

Device: Intervention 3

Device: Intervention 2

Device: Intervention 1