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NCT02451241 Clinical Trial

The Role of Acupuncture for the Treatment of Obstructive Sleep Apnea in Patients With Hypertension

Sleep Apnea, Obstructive Clinical Trial

Official title:
The Role of Acupuncture for the Treatment of Obstructive Sleep Apnea in Patients With Hypertension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02451241
Other study ID # sleep01
Secondary ID
Status Completed
Phase N/A
First received May 19, 2015
Last updated May 1, 2017
Start date February 2015
Est. completion date March 2016

Study information
Verified date May 2017
Source University of Pernambuco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date March 2016
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender All
Age group 30 Years to 65 Years
Eligibility Inclusion Criteria:

- 5<apnea-hypopnea index (AHI)<30 e/h

Exclusion Criteria:

- body mass index > 35 kg/m2

- Previous OSA treatment

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• acupuncture
electroacupuncture

Locations
Country Name City State
Brazil Rodrigo Pedrosa Recife PE

Sponsors (1)
Lead Sponsor Collaborator
University of Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Apnea-hypopnea index (AHI) reduction in AHI 5 weeks
Secondary Sleep quality Improvement in PSQI scores 5 weeks
Secondary Pulse Wave Velocity (PWV) reduction in PWV 5 weeks
Secondary Blood pressure ambulatory blood pressure monitoring (ABPM) 24h reduction 5 weeks
Secondary Quality of life Short Form 36 Health Survey (SF36) scores 5 weeks
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