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Completed

NCT Number: NCT03283072

Effects of Acute Intermittent Hypoxia on Sensory Function in Healthy Adults

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

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unversity of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention 1

Device

15 bouts of 2mins:1min hypoxia:hyperoxia

Intervention 2

Device

15 bouts of 1mins:1min hypoxia:hyperoxia

Intervention 3

Device

8 bouts of 2mins:1min hypoxia:hyperoxia

Intervention 4 (sham)

Device

15 bouts of 1min:1min normoxia

Primary outcomes

  1. Sensory Function

    Time frame: Every 10 minutes for 60 minutes post intervention, average reported

    Thermal thresholds. Average reported.

  2. Temporal Sensory Summation

    Time frame: 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.

  3. Sensory Function - Pressure

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Acronym: SensoryFLO

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 14, 2017
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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