The Role of Acupuncture for the Treatment of Obstructive... | NCT02451241

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

NCT02451241

Sponsor

University of Pernambuco

Status

Completed

Last Update Posted

May 3, 2017Actual

Enrollment

44Actual

Phase

Not Applicable

Conditions

Sleep Apnea, Obstructive

Interventions

acupuncture

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

May 2015Actual

Completion Date

Mar 2016Actual

First Submitted Date

May 19, 2015

First Submission Date that Met QC Criteria

May 20, 2015

First Posted Date

May 21, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2017

Last Update Posted Date

May 3, 2017Actual

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sham acupuncture	Sham Comparator	group will be submitted to placebo electroacupuncture for 20 minutes, two times a week for 5 weeks. Each session lasts about 40 min.	Other: acupuncture
acupuncture	Experimental	group will be submitted to electroacupuncture for 20 minutes, two times a week for 5 weeks. Each session lasts about 40 min.	Other: acupuncture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
acupuncture	Other	electroacupuncture	acupuncture sham acupuncture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Apnea-hypopnea index (AHI)	reduction in AHI	5 weeks

Secondary Outcomes

Measure	Description	Time Frame
Sleep quality	Improvement in PSQI scores	5 weeks
Pulse Wave Velocity (PWV)	reduction in PWV	5 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

body mass index > 35 kg/m2
Previous OSA treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rodrigo Pedrosa		Recife	Pernambuco	50100130	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015670	Acupuncture Therapy

Ancestor Terms

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided