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Breathing Training for Cognitive Impairment
Phase 2
Recruiting
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 60-89,
Intact score for San Diego Brief Assessment of Capacity to Consent (UBACC).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 months post-baseline
Awards & highlights
Study Summary
This trial aims to test whether adding resonance frequency breathing training to an existing cognitive training program will help slow the progression of dementia in people with mild cognitive impairment.
Who is the study for?
This trial is for older adults aged 60-89 with mild cognitive impairment due to Alzheimer's, who score within a specific range on cognitive assessments and can handle daily activities. They must be stable on certain medications if taken, speak English, have good vision and hearing for app use, and not have major cardiovascular diseases or other disqualifying conditions.Check my eligibility
What is being tested?
The study tests whether adding resonance frequency breathing (RFB) to processing speed/attention training (VSOP) enhances brain function in those with mild cognitive impairment. Participants are randomly assigned to combined RFB+VSOP intervention, VSOP with relaxation control, or waitlisted. The goal is to improve autonomic nervous system flexibility and slow dementia progression.See study design
What are the potential side effects?
While the trial does not mention specific side effects of the interventions being tested (RFB and VSOP), participants may experience discomfort from engaging in new mental exercises or using technology required for the training.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 60 and 89 years old.
Select...
I am able to understand and make decisions about my health care.
Select...
I can perform most of my daily activities without help.
Select...
I have concerns about my memory.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 months post-baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 months post-baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
change of ANS flexibility at 14 months from baseline
change of ANS flexibility at 2 months from baseline
change of ANS flexibility at 8 months from baseline
+3 moreSecondary outcome measures
change of instrumental activities of daily living function (IADL) at 14 months from baseline
change of instrumental activities of daily living function (IADL) at 2 months from baseline
change of instrumental activities of daily living function (IADL) at 8 months from baseline
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: RFB+VSOP (MCI)Experimental Treatment2 Interventions
For home-based RFB+VSOP: The investigators will instruct subjects to do 10-minutes of app- guided paced breathing at RF daily; for select days, there will be VSOP training immediately following RFB.
A total of 8 weeks intervention. The investigators will extend the intervention for additional two weeks for make-up sessions.
Group II: RFB+VSOP (HC)Experimental Treatment2 Interventions
this is a new healthy control intervention arm used for testing adherence related items.
For home-based RFB+VSOP: The investigators will instruct subjects to do 10-minutes of app- guided paced breathing at RF daily; for select days, there will be VSOP training immediately following RFB.
A total of 8 weeks intervention. The investigators will extend the intervention for additional two weeks for make-up sessions.
Group III: IR+VSOP (MCI)Active Control2 Interventions
The control IR strategy will be used, set-up of which will be the same as the RFB + VSOP intervention group with IR replacing RFB. A total of 8 weeks intervention. The investigators will extend the intervention for additional two weeks for make-up sessions.
Group IV: IR only (MCI)Placebo Group1 Intervention
Participants randomized to this condition will receive weekly in-person check-in visits, and perform daily 10-minute IR, so that the number of treatment contacts (though not duration) will be equivalent. A total of 8 weeks intervention. The investigators will extend the intervention for additional two weeks for make-up sessions.
Find a Location
Who is running the clinical trial?
University of RochesterLead Sponsor
840 Previous Clinical Trials
534,480 Total Patients Enrolled
Stanford UniversityOTHER
2,395 Previous Clinical Trials
17,341,481 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 60 and 89 years old.I live in my own home or with family.You have a score between 18 and 25 on a test that measures your cognitive abilities.I am able to understand and make decisions about my health care.You have difficulty distinguishing colors.You have had a problem with alcohol abuse that has affected your ability to think clearly within the last 5 years.I have severe depression symptoms that aren't managed with treatment.You cannot have an MRI if you have a pacemaker or are feeling claustrophobic.I have a neurological condition like Parkinson's or Multiple Sclerosis.My medication doses for Alzheimer's, depression, anxiety, or vascular issues have been stable for 3 months.I do not have major heart or stroke-related conditions.I have a legal guardian due to my impaired decision-making capacity.I can perform most of my daily activities without help.I have concerns about my memory.
Research Study Groups:
This trial has the following groups:- Group 1: IR only (MCI)
- Group 2: IR+VSOP (MCI)
- Group 3: RFB+VSOP (HC)
- Group 4: RFB+VSOP (MCI)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Mild Cognitive Impairment Patient Testimony for trial: Trial Name: NCT04522791 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does VSOP present any potential health hazards for individuals?
"Due to the lack of efficacy data, VSOP received a score of 2 on our team's safety scale. However, there is some evidence supporting its security due to it being in Phase 2 clinical trials."
Answered by AI
Are enrollment slots still available for this experiment?
"Affirmative, clinicaltrials.gov reports that this medical trial is in the midst of recruiting subjects. The listing was first posted on August 18th 2020 and last updated September 6th 2022; it is seeking an aggregate of 114 patients from one site."
Answered by AI
What criteria must I meet to enroll in this trial?
"In order to meet the criteria for this study, potential participants must have a diagnosis of mild cognitive impairment (MCI) and be within the age range of 60-89. As such, there are currently 114 slots available in this clinical trial."
Answered by AI
Does this research include volunteers aged 80 or above?
"This experimental trial is for seniors aged between 60 and 89. Clinicaltrials.gov also hosts 24 trials specifically targeting minors as well as 532 studies dedicated to elderly persons over 65 years old."
Answered by AI
What is the current enrolment size for this clinical experiment?
"Affirmative, the information on clinicaltrials.gov implies that this examination is currently searching for participants. The research was uploaded to the website on August 18th 2020 and has been revised since then; it requires 114 patients at a single site."
Answered by AI
Who else is applying?
What state do they live in?
Connecticut
What site did they apply to?
Feng Lin
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Waiting to get onto a trial , thinking thos might be a good fit.
PatientReceived 2+ prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Most responsive sites:
- Feng Lin: < 48 hours
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