Back to resultsThe Role of Acupuncture for the Treatment of Obstructive Sleep Apnea in Patients With Hypertension
Primary Purpose
Sleep Apnea, Obstructive
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Acupuncture
Eligibility Criteria
Inclusion Criteria:
- 5<apnea-hypopnea index (AHI)<30 e/h
Exclusion Criteria:
- body mass index > 35 kg/m2
- Previous OSA treatment
Sites / Locations
- Rodrigo Pedrosa
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
sham acupuncture
acupuncture
Arm Description
group will be submitted to placebo electroacupuncture for 20 minutes, two times a week for 5 weeks. Each session lasts about 40 min.
group will be submitted to electroacupuncture for 20 minutes, two times a week for 5 weeks. Each session lasts about 40 min.
Outcomes
Primary Outcome Measures
Apnea-hypopnea index (AHI)
reduction in AHI
Secondary Outcome Measures
Sleep quality
Improvement in PSQI scores
Pulse Wave Velocity (PWV)
reduction in PWV
Blood pressure
ambulatory blood pressure monitoring (ABPM) 24h reduction
Quality of life
Short Form 36 Health Survey (SF36) scores
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02451241
Brief Title
The Role of Acupuncture for the Treatment of Obstructive Sleep Apnea in Patients With Hypertension
Official Title
The Role of Acupuncture for the Treatment of Obstructive Sleep Apnea in Patients With Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pernambuco
4. Oversight
5. Study Description
Brief Summary
Recent evidences from small studies show potential benefit of acupuncture in the treatment of obstructive sleep apnea (OSA). These studies did not evaluate the benefit of the treatment on the cardiovascular system.
Primary end-point:
To investigate the effects of acupuncture in improving OSA severity among hypertensive patients.
Secondary end-point To investigate the effect of acupuncture in improving the quality of life and sleep assessed by the Short Form 36 (SF-36) questionnaire and Pittsburgh Questionaire (PSQI); To investigate the effect of acupuncture in blood pressure and arterial stiffness
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
Acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sham acupuncture
Arm Type
Sham Comparator
Arm Description
group will be submitted to placebo electroacupuncture for 20 minutes, two times a week for 5 weeks. Each session lasts about 40 min.
Arm Title
acupuncture
Arm Type
Experimental
Arm Description
group will be submitted to electroacupuncture for 20 minutes, two times a week for 5 weeks. Each session lasts about 40 min.
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
electroacupuncture
Primary Outcome Measure Information:
Title
Apnea-hypopnea index (AHI)
Description
reduction in AHI
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Sleep quality
Description
Improvement in PSQI scores
Time Frame
5 weeks
Title
Pulse Wave Velocity (PWV)
Description
reduction in PWV
Time Frame
5 weeks
Title
Blood pressure
Description
ambulatory blood pressure monitoring (ABPM) 24h reduction
Time Frame
5 weeks
Title
Quality of life
Description
Short Form 36 Health Survey (SF36) scores
Time Frame
5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
5<apnea-hypopnea index (AHI)<30 e/h
Exclusion Criteria:
body mass index > 35 kg/m2
Previous OSA treatment
Facility Information:
Facility Name
Rodrigo Pedrosa
City
Recife
State/Province
PE
ZIP/Postal Code
50100130
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
The Role of Acupuncture for the Treatment of Obstructive Sleep Apnea in Patients With Hypertension
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