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

23 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

32

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Alysha Bogard, PhD
  • Numero di telefono: 3038279875
  • Email: abogard@ufl.edu

Luoghi di studio

  • Stati Uniti
    • Florida
      • Gainesville, Florida, Stati Uniti, 32610
        • Reclutamento
        • University of Florida
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Michela Mir, CCC-SLP
        • Investigatore principale:
          • Alysha Bogard, PhD
      • Gainesville, Florida, Stati Uniti, 80303-2181
        • Reclutamento
        • Norman Fixel Institute for Neurological Diseases
        • Contatto:
        • Investigatore principale:
          • Michela Mir, CCC-SLP
        • Investigatore principale:
          • Alysha Bogard, PhD
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: 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).
Comparatore attivo: 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.
Altro: 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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in speech loudness
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in words per breath during connected speech
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Florida

Investigatori

  • Investigatore principale: Michela Mir, CCC-SLP, University of Florida
  • Investigatore principale: Alysha Bogard, PhD, University of Florida

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

20 giugno 2026

Completamento primario (Stimato)

31 dicembre 2028

Completamento dello studio (Stimato)

31 dicembre 2028

Date di iscrizione allo studio

Primo inviato

16 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

23 giugno 2026

Primo Inserito (Effettivo)

29 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IRB202600117

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

Available Starting:

12 months after publication of the primary study results.

Available Ending:

5 years after publication of the primary study results.

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • CODICE_ANALITICO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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