Cross-System Effects of Acute Intermittent Hypercapnia-Based Interventions in PD
19 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
32
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Michlela Mir, CCC-SLP, PhD
- Numéro de téléphone: 352-273-6095
- E-mail: michela.mir@ufl.edu
Sauvegarde des contacts de l'étude
- Nom: Alysha Bogard, PhD
- Numéro de téléphone: 3038279875
- E-mail: abogard@ufl.edu
Lieux d'étude
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Florida
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Gainesville, Florida, États-Unis, 32610
- Recrutement
- University of Florida
-
Contact:
- Alysha Bogard, PhD
- Numéro de téléphone: 3038279875
- E-mail: abogard@ufl.edu
-
Contact:
- Michela Mir, CCC-SLP, PhD
- Numéro de téléphone: 352-273-6095
- E-mail: michela.mir@ufl.edu
-
Chercheur principal:
- Michela Mir, CCC-SLP
-
Chercheur principal:
- Alysha Bogard, PhD
-
Gainesville, Florida, États-Unis, 80303-2181
- Recrutement
- Norman Fixel Institute for Neurological Diseases
-
Contact:
- Alysha Bogard, PhD
- Numéro de téléphone: 3038279875
- E-mail: abogard@ufl.edu
-
Chercheur principal:
- Michela Mir, CCC-SLP
-
Chercheur principal:
- Alysha Bogard, PhD
-
Contact:
- Michela Mir, CCC-SLP, PhD
- Numéro de téléphone: 303-827-9875
- E-mail: michela.mir@ufl.edu
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
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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).
|
|
Comparateur actif: 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.
|
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).
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in speech loudness
Délai: 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
|
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Change in maximum phonation duration
Délai: baseline and 60-minutes post-intervention
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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
Délai: 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
Délai: 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
Délai: 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
|
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Change in fast walking speed
Délai: 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
|
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Correlation between blood-based biomarkers and functional outcomes
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in words per breath during connected speech
Délai: 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).
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baseline and 60 minutes post-intervention
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Change in cough volume acceleration during voluntary cough
Délai: Baseline and 60 minutes post-intervention
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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
|
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Change in airway occlusion pressure
Délai: 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.
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Baseline and 60 minutes post-intervention
|
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Change in quiet breathing minute ventilation
Délai: Baseline and 60 minutes post-intervention
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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).
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Baseline and 60 minutes post-intervention
|
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Association between sleep characteristics and functional outcomes
Délai: Overnight sleep assessment between acclimation and testing visit; functional outcomes measured at baseline and 60 minutes post-intervention
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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.
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Overnight sleep assessment between acclimation and testing visit; functional outcomes measured at baseline and 60 minutes post-intervention
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Michela Mir, CCC-SLP, University of Florida
- Chercheur principal: Alysha Bogard, PhD, University of Florida
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
12 août 2026
Achèvement primaire (Estimé)
31 décembre 2028
Achèvement de l'étude (Estimé)
31 décembre 2028
Dates d'inscription aux études
Première soumission
16 juin 2026
Première soumission répondant aux critères de contrôle qualité
23 juin 2026
Première publication (Réel)
29 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
21 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 août 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Synucleinopathies
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Processus pathologiques
- Maladies des voies respiratoires
- Troubles respiratoires
- Maladies neurodégénératives
- Troubles du mouvement
- Maladies des noyaux gris centraux
- Conditions pathologiques, signes et symptômes
- Aspiration respiratoire
- Maladie de Parkinson
- Troubles parkinsoniens
Autres numéros d'identification d'étude
- IRB202600117
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime 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.
Délai de partage IPD
Available Starting:
12 months after publication of the primary study results.
Available Ending:
5 years after publication of the primary study results.
Critères d'accès au partage 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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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