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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT07674264
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Acute intermittent hypercapnic hypoxia (AIHH) — OTHER
    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) — OTHER
    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).

Study Details

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.

Key Dates

Start date
Jun 20, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Change in speech loudness [ Time Frame: baseline and 60 minutes post-intervention ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Norman Fixel Institute for Neurological DiseasesGainesvilleFlorida80303-2181
Michela Mir, CCC-SLP, PhD
[email protected]
303-827-9875
Alysha Bogard, PhD
[email protected]
3038279875
Michela Mir, CCC-SLP (PRINCIPAL_INVESTIGATOR)
Alysha Bogard, PhD (PRINCIPAL_INVESTIGATOR)
University of FloridaGainesvilleFlorida32610
Michela Mir, CCC-SLP, PhD
[email protected]
352-273-6095
Alysha Bogard, PhD
[email protected]
3038279875
Michela Mir, CCC-SLP (PRINCIPAL_INVESTIGATOR)
Alysha Bogard, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Gainesville, FL

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Norman Fixel Institute for Neurological Diseases· Gainesville, FLUniversity of Florida· Gainesville, FL

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