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

NCT ID: NCT02451241

Last Updated: 2017-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Sleep Apnea, Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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sham acupuncture

group will be submitted to placebo electroacupuncture for 20 minutes, two times a week for 5 weeks. Each session lasts about 40 min.

Group Type SHAM_COMPARATOR

acupuncture

Intervention Type OTHER

electroacupuncture

acupuncture

group will be submitted to electroacupuncture for 20 minutes, two times a week for 5 weeks. Each session lasts about 40 min.

Group Type EXPERIMENTAL

acupuncture

Intervention Type OTHER

electroacupuncture

Interventions

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acupuncture

electroacupuncture

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* body mass index \> 35 kg/m2
* Previous OSA treatment
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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Rodrigo Pinto Pedrosa

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rodrigo Pedrosa

Recife, Pernambuco, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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sleep01

Identifier Type: -

Identifier Source: org_study_id

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