Acute Intermittent Hypoxia and Breathing in Neuromuscular Disease

NCT03645031 | Completed Results

• 2 other identifiers: IRB201801131OCR18018
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

This project seeks to investigate the effects of a single acute intermittent hypoxia (AIH) session on respiratory and non-respiratory motor function and EMG (electromyography) activity on patients with ALS (amyotrophic lateral sclerosis) and healthy controls.

Conditions

Amyotrophic Lateral Sclerosis (ALS); Neuromuscular Diseases

Keywords

acute intermittent hypoxia (AIH); respiratory motor function; hypoxia; normoxia; EMG (electromyography)

Outcome Measures

Primary Outcomes (3)

• Percent Change in Maximal Inspiratory Pressure (MIP)

  MIP is a maximal voluntary static contraction of the inspiratory muscles against a closed valve, measured at the mouth. The test will be repeated until 3 measurements are obtained within 10% variability and an average of the three trials is reported. The change in MIP will be the percent difference in pressure between the averaged baseline MIP and the averaged follow-up measure, which is tested 60 minutes after the gas intervention.

  3 Hours

• Percent Change in Maximal Voluntary Grip Force

  Maximal static voluntary handgrip contractions will be evaluated in a seated position with the arm at the side and elbow flexed to 90 degrees. The test will be repeated until 3 measurements are obtained within 10% variability and then averaged. The change in grip will be the percent difference in force between the averaged baseline grip and the averaged follow-up grip measure, which is tested 60 minutes after the gas intervention.

  3 Hours

• Percent Change in Sniff Nasal Inspiratory Pressure

  Maximal voluntary contractions of the inspiratory muscles measured with a pressure sensor placed in the nare. The test will be repeated until 3 measurements are obtained within 10% variability and then averaged. The change in sniff nasal inspiratory pressure will be the percent difference in pressure between the averaged baseline sniff nasal inspiratory pressure and the averaged follow-up measure, which is tested 60 minutes after the gas intervention.

  3 Hours

Secondary Outcomes (3)

• Percent Change in Minute Ventilation

  3 Hours

• Occlusion Pressure (P0.1)

  3 Hours

• Percentage Change in Respiratory EMG Vector Magnitude

  3 Hours

Study Arms (2)

ALS Group

EXPERIMENTAL

Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH), as well as, the 45 minute sham AIH session, consisting of breathing air with normal oxygen levels. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.

Other: Acute Intermittent Hypoxia; Other: Sham Acute Intermittent Hypoxia

Healthy Control Group

EXPERIMENTAL

Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH), as well as, the 45 minute sham AIH session, consisting of breathing air with normal oxygen levels. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.

Other: Acute Intermittent Hypoxia; Other: Sham Acute Intermittent Hypoxia

Interventions

Acute Intermittent Hypoxia OTHER

AIH entails continuous breathing as the level of oxygen in the air is decreased, then returned to normal. Participants will alternate between breathing normal air and breathing hypoxic air (air that has less oxygen). Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH). Breathing, muscle activity and heart activity will be monitored before, during and after the procedure. The intervals will last 1 minute each.

Also known as: AIH

ALS Group; Healthy Control Group

Sham Acute Intermittent Hypoxia OTHER

Participants will complete the sham acute intermittent hypoxia, consisting of a single 45 minute session of breathing air with normal oxygen levels. All aspects of this procedure will otherwise be the same as for the AIH procedure. Breathing, muscle activity and heart activity will be monitored before, during and after the procedure.

Also known as: Sham AIH

ALS Group; Healthy Control Group

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a healthy adult
• clinical diagnosis of ALS
• baseline FVC \>60% predicted for age, sex and height.

You may not qualify if:

• pregnant
• diagnosed cardiovascular disease
• a BMI \>35 kg/m2
• currently take selective serotonin reuptake inhibitors (SSRI)
• history of seizures
• history of hospitalization for sepsis
• respiratory infection or took antibiotic medications within the past 4 weeks
• use external respiratory support during any waking hours
• participate in a pharmaceutical trial to treat ALS
• have any other medical condition the PI or medical director identify would make it unsuitable to participate.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (2)

UF Clinical Research Center

Gainesville, Florida, 32610, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Neuromuscular Diseases; Hypoxia

Interventions

Insemination, Artificial, Homologous

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Results Point of Contact

• Title: Dr. Barbara K. Smith
• Organization: University of Florida

bksmith@ufl.edu

352-294-5315

Study Officials

• Barbara K Smith, PT, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blind to the order of the AIH/sham AIH visits, but this information will be provided to the participant after completion of last visit.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will complete both the AIH and the sham AIH visits. The order of these visits will be randomized, but all subjects will complete both visits in the course of the study.

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 24, 2018
• Study Start: October 1, 2018
• Primary Completion: June 2, 2023
• Study Completion: June 2, 2023
• Last Updated: May 15, 2025
• Results First Posted: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)