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

23. juni 2026 opdateret af: University of Florida

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

32

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Alysha Bogard, PhD
  • Telefonnummer: 3038279875
  • E-mail: abogard@ufl.edu

Studiesteder

  • Forenede Stater
    • Florida
      • Gainesville, Florida, Forenede Stater, 32610
        • Rekruttering
        • University of Florida
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Michela Mir, CCC-SLP
        • Ledende efterforsker:
          • Alysha Bogard, PhD
      • Gainesville, Florida, Forenede Stater, 80303-2181
        • Rekruttering
        • Norman Fixel Institute for Neurological Diseases
        • Kontakt:
        • Ledende efterforsker:
          • Michela Mir, CCC-SLP
        • Ledende efterforsker:
          • Alysha Bogard, PhD
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: 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).
Aktiv komparator: 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.
Andet: 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in speech loudness
Tidsramme: baseline and 60 minutes post-intervention
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.
baseline and 60 minutes post-intervention
Change in maximum phonation duration
Tidsramme: baseline and 60-minutes post-intervention
Within-subject differences in duration (s) of sustained "ah" pre/post intervention and differences in duration between intervention groups (AIHH vs. AIHN).
baseline and 60-minutes post-intervention
Change in peak expiratory flow rate during voluntary cough
Tidsramme: baseline and 60 minutes post-intervention
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.
baseline and 60 minutes post-intervention
Change in Five-Times Sit-to-Stand performance
Tidsramme: baseline and 60 minutes post-intervention
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).
baseline and 60 minutes post-intervention
Change in Timed Up and Go performance
Tidsramme: baseline and 60 minutes post-intervention
Within-subject differences in duration (s) of Timed Up and Go performance, pre/post intervention. This includes duration of time participants take to stand, walk 3m, turn, walk back 3m, and sit. Differences in duration will also be compared between intervention groups (AIHH vs. AIHN).
baseline and 60 minutes post-intervention
Change in fast walking speed
Tidsramme: baseline and 60 minutes post-intervention
Within-subject differences in duration (s) of 10M walk test, pre/post intervention. Differences in duration will also be compared between intervention groups (AIHH vs. AIHN)
baseline and 60 minutes post-intervention
Correlation between blood-based biomarkers and functional outcomes
Tidsramme: Baseline and 60 minutes post-intervention; genotype assessed at baseline only
Relationship between baseline biomarkers (APOE and BDNF genotype, inflammatory cytokines, serum urate, and circulating α-synuclein) and differences in speech loudness (dB), phonation duration (s), TUG (s), 5x sit-to-stand, and 10M walk test, pre/post intervention in both AIHH and AIHN intervention groups.
Baseline and 60 minutes post-intervention; genotype assessed at baseline only

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in words per breath during connected speech
Tidsramme: baseline and 60 minutes post-intervention
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).
baseline and 60 minutes post-intervention
Change in cough volume acceleration during voluntary cough
Tidsramme: Baseline and 60 minutes post-intervention
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.
Baseline and 60 minutes post-intervention
Change in airway occlusion pressure
Tidsramme: Baseline and 60 minutes post-intervention
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.
Baseline and 60 minutes post-intervention
Change in quiet breathing minute ventilation
Tidsramme: Baseline and 60 minutes post-intervention
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).
Baseline and 60 minutes post-intervention
Association between sleep characteristics and functional outcomes
Tidsramme: Overnight sleep assessment between acclimation and testing visit; functional outcomes measured at baseline and 60 minutes post-intervention
Relationship between sleep-related metrics (apnea-hypopnea index, oxygen saturation index, and sleep fragmentation) and differences in speech loudness (dB), phonation duration (s), TUG (s), 5x sit-to-stand, and 10M walk test, pre/post intervention in both AIHH and AIHN intervention groups. AHI is calculated by dividing total number of apneas/hypopneas by total hours of sleep. ODI is calculated by dividing the number of times %oxygen drops below baseline by total hours of sleep.
Overnight sleep assessment between acclimation and testing visit; functional outcomes measured at baseline and 60 minutes post-intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Florida

Efterforskere

  • Ledende efterforsker: Michela Mir, CCC-SLP, University of Florida
  • Ledende efterforsker: Alysha Bogard, PhD, University of Florida

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

20. juni 2026

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

31. december 2028

Datoer for studieregistrering

Først indsendt

16. juni 2026

Først indsendt, der opfyldte QC-kriterier

23. juni 2026

Først opslået (Faktiske)

29. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB202600117

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data may be made available upon reasonable request following publication of the primary study results and with approval of the study investigators and University of Florida.

IPD-delingstidsramme

Available Starting:

12 months after publication of the primary study results.

Available Ending:

5 years after publication of the primary study results.

IPD-delingsadgangskriterier

De-identified individual participant data (IPD) that underlie the results reported in published manuscripts will be available beginning 12 months following publication of the primary study results and ending 5 years thereafter. Shared data may include demographic characteristics, intervention assignment, speech outcomes, cough outcomes, respiratory outcomes, mobility outcomes, sleep metrics, blood-based biomarker measures, and associated data dictionaries. Investigators who provide a methodologically sound proposal for secondary analyses may request access. Requests will be reviewed by the study investigators and the University of Florida as applicable. Approved investigators will receive access to de-identified datasets and supporting documentation through a secure data-sharing mechanism following execution of any required data use agreements and institutional approvals.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

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