This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

RCT of Effects of Device-guided Breathing on Ambulatory BP (RESPeRate)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Lynn P. Clemow, Ph.D., ABPP, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01184755
First received: August 17, 2010
Last updated: April 11, 2017
Last verified: April 2017
Results First Received: January 11, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Behavioral: Relaxation
Device: RESPeRate

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Resperate Device Used for 8 Weeks   Relaxation Placebo Device   Usual Care
STARTED   126   65   62 
COMPLETED   101   54   56 
NOT COMPLETED   25   11   6 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Resperate Device Used for 8 Weeks   Relaxation Placebo Device   Usual Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 126   65   62   253 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      101  80.2%      51  78.5%      51  82.3%      203  80.2% 
>=65 years      25  19.8%      14  21.5%      11  17.7%      50  19.8% 
Age 
[Units: Years]
Mean (Full Range)
 56.65 
 (23 to 80) 
 57.58 
 (34 to 79) 
 56.34 
 (27 to 76) 
 56.74 
 (23 to 80) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      71  56.3%      33  50.8%      34  54.8%      138  54.5% 
Male      55  43.7%      32  49.2%      28  45.2%      115  45.5% 
Region of Enrollment 
[Units: Participants]
       
United States   126   65   62   253 


  Outcome Measures

1.  Primary:   Change in Systolic and Diastolic BP Measured by Ambulatory BP Monitoring (Waking Averages)   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lynn Clemow, PhD
Organization: Rutgers - Robert Wood Johnson Medical School
phone: 732-235-6972
e-mail: lynn.clemow@rutgers.edu



Responsible Party: Lynn P. Clemow, Ph.D., ABPP, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01184755     History of Changes
Other Study ID Numbers: 526
R01HL083056-01 ( U.S. NIH Grant/Contract )
Study First Received: August 17, 2010
Results First Received: January 11, 2017
Last Updated: April 11, 2017