Trial Outcomes & Findings for RCT of Effects of Device-guided Breathing on Ambulatory BP (NCT NCT01184755)

Last Updated: 2017-05-16

Results Overview

The primary outcome for this study is the change in systolic and diastolic BP measured by Ambulatory BP monitoring at 8-weeks. The measure is the waking mean BP.

Recruitment status

COMPLETED

Study phase

Target enrollment

253 participants

Primary outcome timeframe

8 weeks

Results posted on

2017-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	Resperate Device Used for 8 Weeks Participants to use Resperate device to guide breathing for 8 weeks, then not used for next 8 weeks Device-guided breathing: Participants instructed to practice daily for 15 minutes (guided and timed by the device used at home) RESPeRate	Relaxation Placebo Device Participants use modified device to pace breathing in the 13/minute range for daily practice for 8 weeks and no device thereafter Relaxation: Participants are instructed to use the device (which paces the breath at a constant 13 breaths/minute) daily for 15 minutes (timing set automatically by device). Sham RESPeRate	Usual Care Participants continue their usual medication and other management for their hypertension. All participants (including UC) are given a home BP monitor and asked to take their BP in morning and evening 3 days/week.
Overall Study STARTED	126	65	62
Overall Study COMPLETED	101	54	56
Overall Study NOT COMPLETED	25	11	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RCT of Effects of Device-guided Breathing on Ambulatory BP

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Resperate Device Used for 8 Weeks n=126 Participants Participants to use Resperate device to guide breathing for 8 weeks, then not used for next 8 weeks Device-guided breathing: Participants instructed to practice daily for 15 minutes (guided and timed by the device used at home) RESPeRate	Relaxation Placebo Device n=65 Participants Participants use modified device to pace breathing in the 13/minute range for daily practice for 8 weeks and no device thereafter Relaxation: Participants are instructed to use the device (which paces the breath at a constant 13 breaths/minute) daily for 15 minutes (timing set automatically by device). Sham RESPeRate	Usual Care n=62 Participants Participants continue their usual medication and other management for their hypertension. All participants (including UC) are given a home BP monitor and asked to take their BP in morning and evening 3 days/week.	Total n=253 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	101 Participants n=5 Participants	51 Participants n=7 Participants	51 Participants n=5 Participants	203 Participants n=4 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants	14 Participants n=7 Participants	11 Participants n=5 Participants	50 Participants n=4 Participants
Age, Continuous	56.65 years n=5 Participants	57.58 years n=7 Participants	56.34 years n=5 Participants	56.74 years n=4 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	33 Participants n=7 Participants	34 Participants n=5 Participants	138 Participants n=4 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	32 Participants n=7 Participants	28 Participants n=5 Participants	115 Participants n=4 Participants
Region of Enrollment United States	126 participants n=5 Participants	65 participants n=7 Participants	62 participants n=5 Participants	253 participants n=4 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: These were patients who completed both the baseline and 8-week Ambulatory BP measures.

The primary outcome for this study is the change in systolic and diastolic BP measured by Ambulatory BP monitoring at 8-weeks. The measure is the waking mean BP.

Outcome measures

Outcome measures
Measure	Resperate Device Used for 8 Weeks n=101 Participants Participants to use Resperate device to guide breathing for 8 weeks, then not used for next 8 weeks Device-guided breathing: Participants instructed to practice daily for 15 minutes (guided and timed by the device used at home) RESPeRate	Relaxation Placebo Device n=54 Participants Participants use modified device to pace breathing in the 13/minute range for daily practice for 8 weeks and no device thereafter Relaxation: Participants are instructed to use the device (which paces the breath at a constant 13 breaths/minute) daily for 15 minutes (timing set automatically by device). Sham RESPeRate	Usual Care n=56 Participants Participants continue their usual medication and other management for their hypertension. All participants (including UC) are given a home BP monitor and asked to take their BP in morning and evening 3 days/week.
Change in Systolic and Diastolic BP Measured by Ambulatory BP Monitoring (Waking Averages) Change in Systolic BP	5.8 mm Hg Standard Deviation 10.7	6.6 mm Hg Standard Deviation 12.3	1.2 mm Hg Standard Deviation 9.9
Change in Systolic and Diastolic BP Measured by Ambulatory BP Monitoring (Waking Averages) Change in Diastolic BP	4.0 mm Hg Standard Deviation 7.0	4.7 mm Hg Standard Deviation 7.4	0.5 mm Hg Standard Deviation 7.1

Adverse Events

Resperate Device Used for 8 Weeks

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Relaxation Placebo Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lynn Clemow, PhD

Rutgers - Robert Wood Johnson Medical School

Phone: 732-235-6972

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place