Heart Inflammation and Mental Stress Study (HIMS)
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|ClinicalTrials.gov Identifier: NCT03695146|
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : September 28, 2022
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Behavioral: Paced breathing Behavioral: Active relaxation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Heart Inflammation and Mental Stress Study|
|Actual Study Start Date :||August 19, 2019|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: 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.
Behavioral: 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 Comparator: 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.
Behavioral: Active relaxation
Individuals will be provided with headphones while resting quietly listening to relaxing tones/music.
No Intervention: 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.
- Change in heart rate variability [ Time Frame: Baseline, pre-intervention and up to 60 minutes post-intervention ]Heart rate variability will be measured using a standard electrocardiogram to detect variability in R -to-R intervals.
- Change in cytokine expression in peripheral blood mononuclear cells [ Time Frame: Baseline, pre-intervention and up to 60 minutes post-intervention ]Peripheral blood will be drawn and mononuclear cells isolated and incubated with lipopolysaccharide to induce inflammatory cytokine expression. The change in cytokine expression will be quantified as a function of time.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03695146
|Contact: Roger C McIntosh, Ph.D.||firstname.lastname@example.org|
|Contact: Katie Dillon, M.S.||email@example.com|
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Roger C McIntosh, PhD 305-243-2047 ext 3 firstname.lastname@example.org|
|Principal Investigator: Roger C McIntosh, PhD|
|Principal Investigator:||Roger C McIntosh, Ph.D.||University of Miami, College of Arts and Sciences|