NCT02451241

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

3 months

First QC Date

May 19, 2015

Last Update Submit

May 1, 2017

Conditions

Sleep Apnea, Obstructive

Keywords

Acupuncture

Outcome Measures

Primary Outcomes (1)

  • Apnea-hypopnea index (AHI)

    reduction in AHI

    5 weeks

Secondary Outcomes (4)

  • Sleep quality

    5 weeks

  • Pulse Wave Velocity (PWV)

    5 weeks

  • Blood pressure

    5 weeks

  • Quality of life

    5 weeks

Study Arms (2)

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

acupunctureOTHER

electroacupuncture

acupuncturesham acupuncture

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • body mass index \> 35 kg/m2
  • Previous OSA treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rodrigo Pedrosa

Recife, Pernambuco, 50100130, Brazil

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 19, 2015

First Posted

May 21, 2015

Study Start

February 1, 2015

Primary Completion

May 1, 2015

Study Completion

March 1, 2016

Last Updated

May 3, 2017

Record last verified: 2017-05

Locations

BR(1)