Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Acute Intermittent Hypercapnic Hypoxia | Experimental | 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. |
|
| Group 2: Acute Intermittent Hypercapnic Normoxia | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in speech loudness | 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 | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in words per breath during connected speech | 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 |
Not provided
Inclusion Criteria:
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
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michlela Mir, CCC-SLP, PhD | Contact | 352-273-6095 | michela.mir@ufl.edu | |
| Alysha Bogard, PhD | Contact | 3038279875 | abogard@ufl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michela Mir, CCC-SLP | University of Florida | Principal Investigator |
| Alysha Bogard, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Recruiting | Gainesville | Florida | 32610 | United States |
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.
Available Starting:
12 months after publication of the primary study results.
Available Ending:
5 years after publication of the primary study results.
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.
Not provided
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020734 | Parkinsonian Disorders |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Single blind, randomized parallel study design
Not provided
Not provided
Each arm involves hypercapnia, while only one includes mild hypoxia. The addition of slightly elevated CO2 in each arm facilitates participant blinding.
| 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). |
|
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 | 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 |
| Change in cough volume acceleration during voluntary cough |
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 | 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 | 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 | 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 |
| Norman Fixel Institute for Neurological Diseases | Recruiting | Gainesville | Florida | 80303-2181 | United States |
|
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |