Effects of Acute Intermittent Hypoxia on Sensory Function in Healthy Adults

NCT ID: NCT03283072

Last Updated: 2023-08-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-18

Study Completion Date

2020-07-06

Brief Summary

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

Detailed Description

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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.

Conditions

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Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Within subjects design with randomization of presentation of four different hypoxia/normoxia intervals.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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

Study Groups

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Sequence 1

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)

Group Type EXPERIMENTAL

Intervention 1

Intervention Type DEVICE

15 bouts of 2mins:1min hypoxia:hyperoxia

Intervention 2

Intervention Type DEVICE

15 bouts of 1mins:1min hypoxia:hyperoxia

Intervention 3

Intervention Type DEVICE

8 bouts of 2mins:1min hypoxia:hyperoxia

Intervention 4 (sham)

Intervention Type DEVICE

15 bouts of 1min:1min normoxia

Sequence 2

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

Group Type EXPERIMENTAL

Intervention 1

Intervention Type DEVICE

15 bouts of 2mins:1min hypoxia:hyperoxia

Intervention 2

Intervention Type DEVICE

15 bouts of 1mins:1min hypoxia:hyperoxia

Intervention 3

Intervention Type DEVICE

8 bouts of 2mins:1min hypoxia:hyperoxia

Intervention 4 (sham)

Intervention Type DEVICE

15 bouts of 1min:1min normoxia

Sequence 3

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

Group Type EXPERIMENTAL

Intervention 1

Intervention Type DEVICE

15 bouts of 2mins:1min hypoxia:hyperoxia

Intervention 2

Intervention Type DEVICE

15 bouts of 1mins:1min hypoxia:hyperoxia

Intervention 3

Intervention Type DEVICE

8 bouts of 2mins:1min hypoxia:hyperoxia

Intervention 4 (sham)

Intervention Type DEVICE

15 bouts of 1min:1min normoxia

Sequence 4

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

Group Type EXPERIMENTAL

Intervention 1

Intervention Type DEVICE

15 bouts of 2mins:1min hypoxia:hyperoxia

Intervention 2

Intervention Type DEVICE

15 bouts of 1mins:1min hypoxia:hyperoxia

Intervention 3

Intervention Type DEVICE

8 bouts of 2mins:1min hypoxia:hyperoxia

Intervention 4 (sham)

Intervention Type DEVICE

15 bouts of 1min:1min normoxia

Interventions

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Intervention 1

15 bouts of 2mins:1min hypoxia:hyperoxia

Intervention Type DEVICE

Intervention 2

15 bouts of 1mins:1min hypoxia:hyperoxia

Intervention Type DEVICE

Intervention 3

8 bouts of 2mins:1min hypoxia:hyperoxia

Intervention Type DEVICE

Intervention 4 (sham)

15 bouts of 1min:1min normoxia

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark D Bishop, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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Unversity of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB201700637

Identifier Type: -

Identifier Source: org_study_id

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