Recruiting

AIHH & AIHN

Sponsor:

University of Florida

Code:

NCT07674264

Conditions

Parkinson Disease

Parkinsonism

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Acute intermittent hypercapnic hypoxia (AIHH)

Acute intermittent hypercapnic normoxia (AIHN)

Study Details

Brief summary:

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.

Conditions

Parkinson Disease

Parkinsonism

Study ID

NCT07674264

Start date

Aug 12, 2026

Status verified date

Jun, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. adults 40 to 75 years of age (the latter to reduce the likelihood of cardiovascular disease)
2. diagnosis of idiopathic Parkinsonism with Hoehn and Yahr stages 2-4
3. medically stable with physician clearance
4. ability to ambulate at least 10 feet with/without assistance
5. ability to follow directions
6. willing to abstain from blood donation for the duration of the study

Exclusion Criteria:

1. additional neurologic conditions
2. severe illness or infection, including respiratory/cardiovascular/lung disease, or uncontrolled hypertension
3. inspiratory stridor
4. pregnancy due to unknown tAIH effects on a fetus, although females of childbearing age will not be excluded\*
5. cigarette smoking or vaping within 5 years
6. history of head/neck/lung cancer with the exception of basal cell carcinoma
7. is currently participating in another research study that could influence the results from this study
8. has deep brain stimulation electrodes implanted or has a history of deep brain stimulation
9. 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.

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1: Acute Intermittent Hypercapnic Hypoxia

Each participant randomly allocated to this arm will breathe brief bouts of mild acute intermittent hypercapnic hypoxia as the intervention, with PRE and POST testing of upper airway, axial function, and blood-based biomarkers.

active comparator: Group 2: Acute Intermittent Hypercapnic Normoxia

Each participant randomly allocated to this arm will breathe brief bouts of mild acute intermittent hypercapnic normoxia as the intervention, with PRE and POST testing of upper airway, axial function, and blood-based biomarkers.

Interventions

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).

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Michlela Mir, CCC-SLP, PhD

352-273-6095michela.mir@ufl.edu

Alysha Bogard, PhD

3038279875abogard@ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Michela Mir, CCC-SLP, PhD

352-273-6095michela.mir@ufl.edu

Alysha Bogard, PhD

3038279875abogard@ufl.edu

Principal Investigator:

Michela Mir, CCC-SLP

Norman Fixel Institute for Neurological Diseases

Recruiting

Gainesville, Florida, United States, 80303-2181

Contacts

Michela Mir, CCC-SLP, PhD

303-827-9875michela.mir@ufl.edu

Alysha Bogard, PhD

3038279875abogard@ufl.edu

Principal Investigator:

Michela Mir, CCC-SLP

More Information

Sponsor

University of Florida

Last update posted

Aug 21, 2026

Last verified

Jun, 2026

Keywords

  • Axial function
  • Upper airway
  • Breathing
  • Acute Intermittent Hypercapnic Hypoxia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-08-21.