Examining the Effect of Acute Intermittent Hypoxia on Serum Blood Proteins and Lower Limb Function

NCT ID: NCT06906536

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-08-31

Brief Summary

The goal of this study is to clarify mechanisms of acute intermittent hypoxia and to examine the effect on lower limb function in persons with chronic, incomplete spinal cord injury.

Detailed Description

The goal of this study is to clarify mechanisms of acute intermittent hypoxia by examining changes in blood biomarkers, neural excitability, and hemoglobin mass. We also aim to clarify how these changes relate to changes in lower limb function in persons with chronic, incomplete spinal cord injury by measuring force steadiness and voluntary muscle activation.

Conditions

INCOMPLETE SPINAL CORD INJURY (ASIA D); Able Bodied

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

AIH Group

Participants will be exposed to 4 consecutive days of acute intermittent hypoxia (AIH): 15, 1.5 min episodes at 9% O2 alternating with 21% O2 at 1 min intervals.

Group Type: EXPERIMENTAL

Acute Intermittent Hypoxia (AIH)

Intervention Type: OTHER

4 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals

SHAM Group

Participants will be exposed to 4 consecutive days of normoxia: 15, 1.5 min episodes at 21% O2 alternating with 21% O2 at 1 min intervals.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acute Intermittent Hypoxia (AIH)

4 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18 to 75 years old (the latter to reduce likelihood of heart disease)
• Medically stable with medical clearance from physician to participate
• Motor-incomplete spinal cord injuries at or below C2 and at or above L5
• AIS A-D at initial screen, or other non-traumatic spinal cord injury disorders (e.g. multiple sclerosis, ALS, tumors, acute transverse myelitis, etc.)
• More than 1 year since iSCI to minimize confounds of spontaneous neurological recovery
• Ability to advance one step overground with or without assistive devices;

Exclusion Criteria

• Severe concurrent illness or pain
• Recurrent autonomic dysreflexia
• History of cardiovascular/pulmonary complications
• Concurrent physical therapy
• Pregnant at time of enrollment or planning to become pregnant
• Untreated painful musculoskeletal dysfunction, fracture or pressure sore
• History of seizures or epilepsy
• Recurring headaches
• Concussion within the last six months
• Depression or manic disorder
• Metal implants in the head, or pacemaker
• Aversion to needles

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

University of Colorado, Boulder

OTHER

Sponsor Role: lead

Responsible Party

Andrew Quesada Tan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Andrew Tan

Boulder, Colorado, United States

Countries

United States

Other Identifiers

1R03HD115657-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-1275

Identifier Type: -

Identifier Source: org_study_id