Acute Intermittent Hypoxia and Breathing in Neuromuscular Disease (AIH-ALS)

University of Florida

Status: Completed

Conditions: Neuromuscular Diseases; Amyotrophic Lateral Sclerosis (ALS)

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03645031

IRB201801131

OCR18018 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Most ALS patients survive less than 5 years after diagnosis, and the main cause of death is respiratory failure. The investigators are interested in the therapeutic potential of acute intermittent hypoxia (AIH) for individuals with neuromuscular diseases, such as ALS. More than two decades of research indicates AIH elicits meaningful respiratory and non-respiratory motor recovery. Acute intermittent hypoxia (AIH) consists of alternating periods of breathing mildly hypoxic (lowered oxygen concentration) and normoxic (normal oxygen concentration) air.

The investigators propose to study mechanisms of respiratory plasticity associated with a single presentation of mild AIH. The fundamental hypothesis guiding this proposal is that even a single AIH trial improves respiratory (and non-respiratory) motor function in ALS patients procedure. Participants will then be asked to breathe air with reduced oxygen for short periods of time, for a duration of 45 minutes. The activity of your muscles and your heart function will be monitored throughout the procedure.

Enrollment: 29 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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29 participants in 2 patient groups

ALS Group

Experimental group

Description:

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.

Treatment:

Other: Acute Intermittent Hypoxia

Other: Sham Acute Intermittent Hypoxia

Healthy Control Group

Experimental group

Description:

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.

Treatment:

Other: Acute Intermittent Hypoxia

Other: Sham Acute Intermittent Hypoxia