Spaulding Rehabilitation Hospital
Cambridge, Massachusetts, 02138, United States
Location status: Recruiting
NCT Number: NCT06514950
The goal of this interventional study is to understand how regular yogic breathing practice, particularly a slow resistive yogic breathing technique called Ujjayi, would benefit individuals between the ages of 18 and 60 with spinal cord injuries. Previously yogic breathing has shown to improve respiratory function and sleep- we'd like to explore this further.
The main questions this study aims to answer are:
* How does Ujjayi breathing affect breathing patterns in individuals with spinal cord injuries? * How does Ujjayi breathing affect lung function in individuals with spinal cord injuries? * How does Ujjayi breathing affect the part of the nervous system responsible for ventilatory control in individuals with spinal cord injuries? * How does Ujjayi breathing affect ventilatory perfusion (how well air and blood flow match in the lungs for efficient gas exchange) in individuals with spinal cord injuries? * How does Ujjayi breathing affect sleep quality in individuals with spinal cord injuries?
Participants will undergo six weeks of training in Ujjayi breathing. Before and after this period, they will visit the lab for measurements of blood pressure, pulse, blood oxygen levels, and breathing. They will also perform several tests:
* Pulmonary function testing to assess lung capacity and respiratory muscle strength. * Pace breathing frequency to four pre-recorded audio files at various breathing rates. * Breathing exercises involving higher levels of carbon dioxide for a short time. * Breathing exercises involving lower levels of oxygen for a short time. * At-home sleep evaluation.
Between the two laboratory testing sessions, participants will practice yogic resistance breathing (Ujjayi breathing) for six weeks.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
Cambridge, Massachusetts, 02138, United States
Location status: Recruiting
This study investigates the impact of a type of slow-resistive yogic breathing, Ujjayi Pranayama, on cardiopulmonary function in 20 men and women aged 18-60 with spinal cord injuries classified under the American Spinal Injury Association Impairment Scale (AIS) score of A, B, or C. Participants will undergo baseline and post-intervention laboratory assessments over six weeks at Spaulding Hospital Cambridge, with cardiovascular and respiratory measurements taken during controlled and uncontrolled breathing conditions. Ujjayi Pranayama training, focusing on resistance breathing during exhalation and inhalation, will include coaching sessions in weeks 1 and 4, supplemented by virtual support for home practice (~20 min, twice daily). The study aims to determine whether regular yogic breathing practice enhances sleep quality, hypercapnic ventilatory response, and overall cardiopulmonary synchrony, potentially reducing respiratory and cardiovascular risks associated with SCI.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will undergo 6 weeks of resistive yogic breathing (Ujjayi) upon exhalation (first three weeks) and upon inhalation and exhalation (second three weeks).
Other names: resistive breathing
Time frame: Change in ventilatory pattern, Time Frame: Baseline, Week 6
Ventilatory patterns measured as rate and regularity by breathing belts (pneumobelts). A normal respiratory rate for an adult at rest is 12 to 18 breaths per minute.
Time frame: Change in pulmonary function, Time Frame: Baseline, Week 6
Pulmonary function measured by spirometry, maximal voluntary ventilation, and maximum inspiratory and expiratory pressures. Results will be reported as forced vital capacity (FVC), Forced Expiratory Volume in 1 second (FEV1), FEV1/FVC ratio, Peak Expiratory Flow (PEF), and Forced Expiratory Flow (FEF) 25%-75%. An absolute range cannot be provided as it depends on various factors such as injury level, completeness of injury, age, race, and sex. In healthy adults, MVV is typically around 120-170 liters per minute (L/min).
Time frame: Change in central and peripheral chemosensitivity, Time Frame: Baseline, Week 6
The Read rebreathing method assesses neural drive to breathe and CO2 sensitivity (central chemosensitivity). A three-way valve connects the breathing circuit to room air or 95% O2-5% CO2. Subjects exhale to functional residual capacity, then rebreathe until PETCO2 reaches 55 mmHg, they can't continue, SPO2 drops below 95%, or 10 minutes elapse. Peripheral chemosensitivity uses brief exposures to hypercapnic (10% CO2, 21% O2) or hypoxic gas (pure nitrogen). Ventilatory response is measured over up to 30 seconds, followed by room air. Each test takes about 15 minutes. Tests are conducted seated and supine. Chemosensitivity is measured by plotting ventilation against pulmonary gas levels.
Time frame: Change in ventilatory perfusion, Time Frame: Baseline, Week 6
Ventilatory perfusion will be calculated from mixed expired and end tidal CO2 measures. The V/Q ratio in healthy lungs is close to 1- this means that ventilation (V) matches perfusion (Q) almost perfectly in well-ventilated alveoli. Certain pathologies could increase or decrease the V/Q ratio.
Time frame: Change in sleep quality, Time Frame: Baseline, Week 6
Sleep quality is assessed using two methods: the PROMIS Sleep Disturbance Short Form and NoxA1 polysomnography. The PROMIS survey provides raw scores that are converted into T-scores. T-scores falling between 40 and 59 indicate average sleep disturbance levels, considered within the normal range. Scores above 60 suggest more sleep disturbances than average, while scores below 39 indicate less disturbance compared to average.
NoxA1 polysomnography records several parameters including EEG waves for sleep stages, wake after onset, nocturnal disturbances, maximum and minimum heart rates at rest, breathing rates, limb movements, teeth grinding (monitored via chin movement sensors), blood oxygen saturation, and respiratory patterns.
Contact information is provided by the study sponsor or research team.
J. Andrew Taylor, MS, PhD
CONTACT
Maria Sukhoplyasova, BSc
CONTACT
Spaulding Rehabilitation Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06455137
Central Nervous System Diseases, Nervous System Diseases
Hualien City, Taiwan
View Trial DetailsNCT06438471
Bone Diseases, Central Nervous System Diseases
Augusta, Georgia, United States
View Trial DetailsNCT00623389
Brain Diseases, Cardiovascular Diseases
Cleveland, Ohio, United States
View Trial DetailsNCT05321017
Central Nervous System Diseases, Nervous System Diseases
Charleston, South Carolina, United States
View Trial Details