Cross-System Effects of Acute Intermittent Hypercapnia-Based Interventions in PD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorUniversity of Florida
About this trial
Parkinsonism impairs upper airway and axial motor control, leading to disordered breathing, reduced speech volume, and ineffective cough. Symptoms are poorly addressed by current therapies. This randomized pilot trial tests whether a single session of acute intermittent hypercapnic hypoxia (AIHH) or hypercapnic normoxia (AIHN) improves upper airway and axial motor function in Parkinsonism, and explores biomarker correlates of intervention responsiveness.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adults 40 to 75 years of age (the latter to reduce the likelihood of cardiovascular disease)
diagnosis of idiopathic Parkinsonism with Hoehn and Yahr stages 2-4
medically stable with physician clearance
ability to ambulate at least 10 feet with/without assistance
Disqualifiers
additional neurologic conditions
severe illness or infection, including respiratory/cardiovascular/lung disease, or uncontrolled hypertension
inspiratory stridor
pregnancy due to unknown tAIH effects on a fetus, although females of childbearing age will not be excluded*
Trial design
Design model
Parallel
Treatments tested in this trial
Acute intermittent hypercapnic hypoxia (AIHH)
Other interventionParticipants randomized to Group 1 will breathe brief bouts of AIHH, involving 15, 1.5-min exposures to 9-10% O2 and 4-5% CO2, alternated with 1 minute of 21% O2 (room air).
Acute intermittent hypercapnic normoxia (AIHN)
Other interventionParticipants randomized to Group 2 will breathe brief bouts of AIHN, involving 15, 1.5-min exposures to 21% O2 and 4-5% CO2, alternated with 1 minute of 21% O2 (room air).
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Group 1: Acute Intermittent Hypercapnic HypoxiaExperimental treatment 1 intervention
Group B: Group 2: Acute Intermittent Hypercapnic NormoxiaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in speech loudness
Within-subject differences in sound pressure level (decibels) pre/post intervention and differences between intervention groups (AIHH vs. AIHN) during sustained phonation and connected speech.
Time frame
baseline and 60 minutes post-intervention2
Change in maximum phonation duration
Within-subject differences in duration (s) of sustained "ah" pre/post intervention and differences in duration between intervention groups (AIHH vs. AIHN).
Time frame
baseline and 60-minutes post-intervention3
Change in peak expiratory flow rate during voluntary cough
Within-subject differences in peak expiratory flow rate (L/s) produced during maximal volitional cough production, pre/post intervention, and between group (AIHH vs. AIHN) differences in peak expiratory flow rate.
Time frame
baseline and 60 minutes post-intervention4
Change in Five-Times Sit-to-Stand performance
Within-subject differences in average time (s) to complete 5 times sit-to-stand task, pre/post intervention, and differences between intervention groups (AIHH vs. AIHN).
Time frame
baseline and 60 minutes post-interventionSecondary outcomes
1
Change in words per breath during connected speech
Within-subject differences in the total number of words produced per breath while reading aloud Grandfather Passage, pre/post intervention. Words per breath will also be measured and compared between intervention groups (AIHH vs. AIHN).
Time frame
baseline and 60 minutes post-intervention2
Change in cough volume acceleration during voluntary cough
Within-subject differences in cough volume acceleration (L/s²) during maximal volitional cough production, pre/post intervention, and between groups (AIHH vs. AIHN). Cough volume acceleration is calculated as peak expiratory flow divided by peak expiratory flow rise time.
Time frame
Baseline and 60 minutes post-intervention3
Change in airway occlusion pressure
Within-subject differences in mouth occlusion pressure (P0.1) measured in cmH2O, pre/post intervention, and between group differences (AIHH vs. AIHN). P0.1 is the pressure generated at the mouth during the first 0.1 seconds of inspiration against an occluded airway.
Time frame
Baseline and 60 minutes post-intervention4
Change in quiet breathing minute ventilation
Within-subject differences in minute-ventilation (L/min ), pre/post intervention, and between group differences (AIHH vs. AIHN) measured during 20 minutes of quiet breathing. Minute ventilation is the calculated using breathing frequency (breaths per minute) x tidal volume (L).
Time frame
Baseline and 60 minutes post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov