Recruiting

Daily Intermittent Hypoxia

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT03262766

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Acute Intermittent Hypoxia (AIH)

Upper extremity training

Sham Acute intermittent hypoxia

Study Details

Brief summary:

The purpose of this research study is to investigate the effectiveness of a combinatorial therapy of breathing low oxygen in short bursts-acute intermittent hypoxia (AIH) and upper limb training on arm strength and function, and comparing it with individual treatments in persons with spinal cord injuries.

The investigators hypothesize that a combinatorial intervention with AIH therapy + upper limb training will be significantly more effective in improving hand function, compared to individual treatments alone.

To test this hypothesis, the investigators will determine the impact of combined daily AIH therapy and high-repetition task-specific upper extremity training on arm strength and hand dexterity in persons with spinal cord injuries.

Conditions

Spinal Cord Injuries

Study ID

NCT03262766

Start date

Jun 24, 2017

Status verified date

Feb, 2020

Completion date

Oct 30, 2020

Anticipated

Primary completion date

Oct 30, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Motor incomplete SCI at or below C2 and above T2 with non-progressive etiology
2. Age between 18 to 70 years
3. More than 1 year since SCI
4. Ability to close and open one's hand without assistance.
5. Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

1. Presence of any of the following medical conditions: congestive heart failure, arrhythmia, uncontrolled high blood pressure, uncontrolled diabetes mellitus, COPD/emphysema and severe asthma.
2. Weight over 250 pounds.
3. Persons with known coronary artery disease, a history of myocardial infarction and known carotid or intracerebral artery stenosis.
4. A medical clearance will be required if patients are taking any other investigational agents.
5. Women who are pregnant or nursing will be excluded, as the potential effects of intermittent hypoxia on pregnant women and fetus are unknown.
6. Individuals with tracheostomy will be excluded.
7. Subjects cannot pursue other research studies which may interfere with our treatment.
8. Subjects with diagnosed obstructive sleep apnea will be excluded as that may affect the response or sensitivity to AIH,
9. Orthopedic injuries or recent surgeries affecting the mobility of upper extremity and shoulder

We will not include the following populations:

  • Adults unable to consent, unless accompanied by a legally authorized representative.
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Acute intermittent hypoxia (AIH)

Subjects will be exposed to acute intermittent hypoxia, daily for 5 days. Each session will consist of up to 90 seconds of 9-10% Oxygen (FiO2 0.09), alternating with up to 90 seconds of 21% Oxygen (normoxic air FiO2 0.21). The delivery of hypoxia and normoxic air mixtures will be repeated up to 18 times per session each, for up to 45 minutes, to maintain SpO2 at 80-90%. If the SpO2 drops below 75%, hypoxia exposure will be terminated immediately.

There is continuous monitoring of respiratory rate, heart rate and peripheral arterial oxyhemoglobin saturation (SpO2).

experimental: AIH+ Upper extremity training

Subjects will be exposed to acute intermittent hypoxia, daily for 5 days. Each session will consist of up to 90 seconds of 9-10% Oxygen (FiO2 0.09), alternating with up to 90 seconds of 21% Oxygen (normoxic air FiO2 0.21). The delivery of hypoxia and normoxic air mixtures will be repeated up to 18 times per session each, for up to 45 minutes, to maintain SpO2 at 80-90%. If the SpO2 drops below 75%, hypoxia exposure will be terminated immediately.

There is continuous monitoring of respiratory rate, heart rate and peripheral arterial oxyhemoglobin saturation (SpO2).

Following the AIH protocol, subjects will receive 45 minutes of task-specific, high repetition upper extremity training, given using an upper-limb robotic rehabilitation device, the Armeo Spring®.

active comparator: Sham AIH + Upper extremity training

Subjects will be exposed to sham hypoxia daily for 5 days. Each session will consist of up to 90 seconds of 21% Oxygen (FiO2 0.21), alternating with up to 90 seconds of 21% Oxygen (normoxic air FiO2 0.21). The delivery will be repeated up to 18 times per session each, for a total of up to 45 minutes.

There is continuous monitoring of respiratory rate, heart rate and peripheral arterial oxyhemoglobin saturation (SpO2).

Following the sham AIH protocol, subjects will receive 45 minutes of task-specific, high repetition upper extremity training. Upper extremity training will be given using an upper-limb robotic rehabilitation device, the Armeo Spring®.

sham comparator: Sham Acute intermittent hypoxia

Subjects will be exposed to sham hypoxia daily for 5 days. Each session will consist of up to 90 seconds of 21% Oxygen (FiO2 0.21), alternating with up to 90 seconds of 21% Oxygen (normoxic air FiO2 0.21). The delivery will be repeated up to 18 times per session each, for a total of up to 45 minutes.

There is continuous monitoring of respiratory rate, heart rate and peripheral arterial oxyhemoglobin saturation (SpO2).

Interventions

Acute Intermittent Hypoxia (AIH)

This will consist of up to 90 seconds of 9-10% O2 (FiO2 0.09), alternating with up to 90 seconds of 21% O2 (normoxic air FiO2 0.21). The delivery of hypoxia and normoxic air mixtures will be repeated up to 18 times per session each, for a total of up to 45 minutes.

Upper extremity training

Subjects will receive 45 minutes of task-specific, high repetition upper extremity training, given using an upper-limb robotic rehabilitation device, the Armeo Spring®. Armeo Spring is a gravity support system based on an ergonomic arm exoskeleton with integrated springs. It cradles the entire arm, from shoulder to the hand, and counterbalances the weight of the user's arm. Therefore, it enhances any residual function and neuromuscular control, and assists in active movement across a large 3-D workspace. The Armeo software contains an extensive library of game-like movement exercises supported by a virtual-reality training environment that displays the functional task along with immediate performance feedback.

Sham Acute intermittent hypoxia

This will consist of up to 90 seconds of 21% O2 (FiO2 0.21), alternating with up to 90 seconds of 21% O2 (normoxic air FiO2 0.21). The delivery of alternating normoxic air will be repeated up to 18 times per session each, for a total of up to 45 minutes.

Primary outcome measure

  • Grip strength (Hydraulic Handheld Dynamometer) [ Time Frame: 10-12 minutes ]

Central Contacts and Locations

Central contacts

Milap Sandhu, PT, PhD

312-238-6529m-sandhu@northwestern.edu

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60610

Contacts

Milap Sandhu, PT, PhD

312-238-6529m-sandhu@northwestern.edu

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

Feb 19, 2020

Last verified

Feb, 2020

Keywords

  • Acute Intermittent Hypoxia
  • Upper Extremity Training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2020-02-19.