Effects of Acute Intermittent Hypoxia on Sensory Function in Healthy Adults

NCT03283072 | Completed Results FDA Device

• 1 other identifier: IRB201700637
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sensitivity

Keywords

thermal threshold; pressure pain threshold; temporal summation

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

Sequence 1

EXPERIMENTAL

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

Sequence 2

EXPERIMENTAL

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

Sequence 3

EXPERIMENTAL

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

Sequence 4

EXPERIMENTAL

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

Interventions

Intervention 1 DEVICE

15 bouts of 2mins:1min hypoxia:hyperoxia

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Intervention 2 DEVICE

15 bouts of 1mins:1min hypoxia:hyperoxia

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Intervention 3 DEVICE

8 bouts of 2mins:1min hypoxia:hyperoxia

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Intervention 4 (sham) DEVICE

15 bouts of 1min:1min normoxia

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 40 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Unversity of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Results Point of Contact

• Title: Mark Bishop
• Organization: University of Florida

bish@ufl.edu

3522736112

Study Officials

• Mark D Bishop, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within subjects design with randomization of presentation of four different hypoxia/normoxia intervals.

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 14, 2017
• Study Start: September 18, 2017
• Primary Completion: July 6, 2020
• Study Completion: July 6, 2020
• Last Updated: August 21, 2023
• Results First Posted: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)