Breathing Practice for Brain and Mental Health in Cancer and Neurodegenerative Diseases
Recruiting · NCT06788886 · Interventional (participants receive a specific treatment) · Lead sponsor: Mayo Clinic
View the official record on ClinicalTrials.gov →Interventions studied
Biospecimen CollectionExercise InterventionMagnetic Resonance ImagingQuestionnaire AdministrationRespiratory Therapy
What this trial is about
This clinical trial studies the effect of respiratory training for enhancing brain and mental health among patients with multiple sclerosis (MS) and cancer (along with their caregivers). The relationship between respiration, cardiovascular effects in the brain, mental health, and neurophysiological mechanisms are significant for patient populations facing complex health challenges, such as those with cancer and neurodegenerative disease, and their caregivers. By measuring oxygen delivery to brain tissues and cerebrospinal fluid flow, this trial may help researchers investigate the potential benefits of respiratory training for patients with MS and cancer and their caregivers.
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- STUDY 1: Participants must be physically fit enough to perform light exercise.
- STUDY 1: Should read and understand English well enough to consent, complete measures, and follow instructions.
- STUDY 1: Must have access to a smartphone or tablet.
- STUDY 2: Participants must be physically fit enough to perform light exercise.
- STUDY 2: Cancer patients may have prostate cancer, neuroendocrine tumor, or brain cancer in any stage.
- STUDY 2: The main focus is on pairs of cancer patients and their respective caregivers, but individual cancer patients or individual caregivers are also acceptable.
- STUDY 2: Participants should read and understand English well enough to consent, complete measures, and follow instructions.
- STUDY 2: They also must have access to a smartphone or tablet.
- STUDY 3: Participants must be physically fit enough to perform light exercise.
- STUDY 3: The patient should have multiple sclerosis.
- STUDY 3: Participants should read and understand English well enough to consent, complete measures, and follow instructions.
- STUDY 3: They also must have access to a smartphone or tablet.
Exclusion criteria
- STUDY 1: Participants incompatible with MRI machines due to factors such as pacemakers or metallic implants.
- STUDY 1: Additionally, those with chronic medical conditions, including heart disease (coronary artery disease, congestive heart failure, hypertension, cardiac arrhythmia), chronic obstructive pulmonary disease (COPD), cystic fibrosis, cancer, diabetes, sleep apnea, aneurysms, and neurological conditions (epilepsy, Alzheimer's disease, Huntington' disease, essential tremor and Parkinson disease) are excluded.
- STUDY 1: Participants with psychiatric conditions such as psychosis, suicidality, bipolar disorder, major depression, and substance use disorders are excluded.
- STUDY 1: Participants serving as caregivers for any of the aforementioned conditions and for other illnesses such as cancer or neurological disorders, are also excluded.
- STUDY 1: Further exclusions apply to those with severe vision, hearing impairments, have a body mass index (BMI) over 30, and those who are pregnant.
- STUDY 1: Those planning to become pregnant during the study period will be excluded.
- STUDY 2: Participants incompatible with MRI machines due to factors such as pacemakers or metallic implants are excluded, as are those with chronic lung disease (chronic obstructive pulmonary disease \[COPD\], cystic fibrosis), aneurysms, and those who are pregnant.
- STUDY 2: Those planning to become pregnant during the study period will be excluded.
- STUDY 3: Participants incompatible with MRI machines due to factors such as pacemakers or metallic implants are excluded, as are those with chronic lung disease (chronic obstructive pulmonary disease \[COPD\], cystic fibrosis), aneurysms, and those who are pregnant.
- STUDY 3: Those planning to become pregnant during the study period will be excluded.
Where it is running
1 location listed across 1 US state.
- Mayo Clinic in Rochester - Rochester, Minnesota, United States