Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2019-08-19
2023-12-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Paced breathing
Individuals will be asked to sit in a quiet room while sensors collect their heart rate, respiratory rate and blood pressure for approximately 45 minutes. Individuals in this arm will engage in a paced breathing. Initial respiratory rate will be measured with a transducer. Participants will be connected to a paced breathing device (RESPERATE) that will gradually reduce the pace of audio tones presented to those individuals from spontaneous breathing rate down to 6 - 8 breaths per minute.
Paced breathing
Individuals will be fitted with a respiratory transducer and receive auditory tones with which to pace their rate of inspiration and expiration in the experimental group.
Relaxing music
Individuals will be asked to sit in a quiet room while sensors collect their heart rate, respiratory rate and blood pressure for approximately 45 minutes. Individuals will be provided with an audio device that plays soothing/relaxing music at a similar range (beats per minute) of the auditory signal presented during the experimental condition. Subjects will not be instructed how to breathe in this arm.
Active relaxation
Individuals will be provided with headphones while resting quietly listening to relaxing tones/music.
No intervention
Individuals will be asked to sit in a quiet room while sensors collect their heart rate, respiratory rate and blood pressure for approximately 45 minutes.
No interventions assigned to this group
Interventions
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Paced breathing
Individuals will be fitted with a respiratory transducer and receive auditory tones with which to pace their rate of inspiration and expiration in the experimental group.
Active relaxation
Individuals will be provided with headphones while resting quietly listening to relaxing tones/music.
Eligibility Criteria
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Inclusion Criteria
2. HIV-antibody testing.
Exclusion Criteria
2. current or lifetime history of cardiovascular disease diagnosis or treatment including pulmonary stenosis, heart valve abnormalities and hypertension;
3. current or lifetime diagnoses of cancer, kidney/liver disease, hypertension, Type 1 or Type 2 diabetes;
4. history of trauma, cerebral infarction or hemorrhage;
5. current diagnosis and/or treatment for hypertension;
6. severe cognitive impairment;
7. current treatment or diagnosis of psychiatric illness;
8. metal implants or debris within the body; or pregnancy;
9. body mass index \> 35;
10. use of hormone replacement therapy; and current smoker.
21 Years
65 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Miami
OTHER
Responsible Party
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Roger McIntosh
Assistant Professor
Principal Investigators
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Roger C McIntosh, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Miami, College of Arts and Sciences
Locations
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University of Miami
Miami, Florida, United States
Countries
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Other Identifiers
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20180631
Identifier Type: -
Identifier Source: org_study_id
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