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Recruiting NCT07674264

Cross-System Effects of Acute Intermittent Hypercapnia-Based Interventions in PD

No phase Interventional Parkinson Disease Parkinsonism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acute intermittent hypercapnic hypoxia (AIHH), Acute intermittent hypercapnic normoxia (AIHN).
Who it may be relevant to
Registry conditions: Parkinson Disease, Parkinsonism. Basic parameters: 40 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Pilot Study of Acute Intermittent Hypercapnia-Based Interventions on Upper Airway and Axial Motor Function in Parkinson's Disease

Overview

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.

Interventions

  • Other Acute intermittent hypercapnic hypoxia (AIHH)
    Participants 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).
  • Other Acute intermittent hypercapnic normoxia (AIHN)
    Participants 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).

Primary outcome measures

  • Change in speech loudness [Time frame: baseline and 60 minutes post-intervention]
  • Change in maximum phonation duration [Time frame: baseline and 60-minutes post-intervention]
  • Change in peak expiratory flow rate during voluntary cough [Time frame: baseline and 60 minutes post-intervention]
  • Change in Five-Times Sit-to-Stand performance [Time frame: baseline and 60 minutes post-intervention]
  • Change in Timed Up and Go performance [Time frame: baseline and 60 minutes post-intervention]
  • Change in fast walking speed [Time frame: baseline and 60 minutes post-intervention]
  • Correlation between blood-based biomarkers and functional outcomes [Time frame: Baseline and 60 minutes post-intervention; genotype assessed at baseline only]
Secondary outcome measures (5)
  • Change in words per breath during connected speech [Time frame: baseline and 60 minutes post-intervention]
  • Change in cough volume acceleration during voluntary cough [Time frame: Baseline and 60 minutes post-intervention]
  • Change in airway occlusion pressure [Time frame: Baseline and 60 minutes post-intervention]
  • Change in quiet breathing minute ventilation [Time frame: Baseline and 60 minutes post-intervention]
  • Association between sleep characteristics and functional outcomes [Time frame: Overnight sleep assessment between acclimation and testing visit; functional outcomes measured at baseline and 60 minutes post-intervention]

Eligibility criteria

Inclusion criteria

  • 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
  • ability to follow directions
  • willing to abstain from blood donation for the duration of the study

Exclusion criteria

  • 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\*
  • cigarette smoking or vaping within 5 years
  • history of head/neck/lung cancer with the exception of basal cell carcinoma
  • is currently participating in another research study that could influence the results from this study
  • has deep brain stimulation electrodes implanted or has a history of deep brain stimulation
  • faints or becomes lightheaded at the sight of blood
  • If a female of childbearing potential indicates there is a chance she could be pregnant, she will be provided a pregnancy test and allowed to continue in the study if negative. This is because the fetal risks associated with intermittent hypoxia are unknown.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • University of Florida — Gainesville
  • Norman Fixel Institute for Neurological Diseases — Gainesville

Identifiers

NCT: NCT07674264 · IRB202600117

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗