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Acupuncture as Adjuvant Therapy for Sleep Disorders in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease

Eligibility Criteria

38 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with Idiopathic Parkinson's disease
  • Mini Mental State Examination (MMSE) According to education
  • Stages 1, 2 and 3 in the Hoehn-Yahr scale.

Exclusion Criteria:

  • Patients who have another neurological disorder associated with Parkinson's disease
  • Cardiac with pacemaker (contraindicated the use of electrotherapy).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental

    Control

    Arm Description

    Acupuncture was applied on the acupoints F3 - BP6- VB34- IG4 - TA5 - C7 - PC6 - IG11 - VB20 - XIAOCHANXUE, once a week, eight sessions in the experimental group.

    The control group no suffered intervention.

    Outcomes

    Primary Outcome Measures

    Scale for Parkinson's disease (PDSS)
    A self-administered scale designed to assess nighttime sleep problems, sleep disorders and excessive daytime sleep. Consists of 15 items represented by a ruler (10 cm) where the patient indicates the frequency of the symptom from 0 (always)- 10 (never).

    Secondary Outcome Measures

    Full Information

    First Posted
    March 22, 2016
    Last Updated
    April 1, 2016
    Sponsor
    Universidade Federal de Pernambuco
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02731677
    Brief Title
    Acupuncture as Adjuvant Therapy for Sleep Disorders in Parkinson's Disease
    Official Title
    Acupuncture as Adjuvant Therapy for Sleep Disorders in Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    February 2016 (Actual)
    Study Completion Date
    February 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal de Pernambuco

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Sleep disorders correspond to a non-motor symptom present in DP, being represented by daytime sleepiness and maintenance insomnia. This study aims to evaluate the effects of acupuncture on sleep disorders in patients with PD assisted by Pró-Parkinson Program at University Hospital of Pernambuco, Brazil. Its a randomized clinical trial approved by the Ethics Committee for Research with Human. It was included patients with diagnosed with Idiopathic Parkinson's disease, Mini Mental State Examination (MMEE) according to education, stages 1, 2 and 3 in the Hoehn-Yahr scale. It was used the sleep Scale for Parkinson's disease (PDSS), a self-administered scale designed to assess nighttime sleep problems, sleep disorders and excessive daytime sleep. Twenty-two subjects were allocated in two groups: experimental and control. Acupuncture was applied on the acupoints F3 - BP6- VB34- IG4 - TA5 - C7 - PC6 - IG11 - VB20 - XIAOCHANXUE once a week, eight sessions in the experimental group. The control group no suffered intervention. The paired analyzes were performed using the Wilcoxon test and the independent analyzes using the Mann-Whitney test.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    Acupuncture was applied on the acupoints F3 - BP6- VB34- IG4 - TA5 - C7 - PC6 - IG11 - VB20 - XIAOCHANXUE, once a week, eight sessions in the experimental group.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    The control group no suffered intervention.
    Intervention Type
    Other
    Intervention Name(s)
    Acupuncture
    Intervention Description
    Acupuncture was applied on the acupoints F3 - BP6- VB34- IG4 - TA5 - C7 - PC6 - IG11 - VB20 - XIAOCHANXUE, once a week, eight sessions in the experimental group.
    Primary Outcome Measure Information:
    Title
    Scale for Parkinson's disease (PDSS)
    Description
    A self-administered scale designed to assess nighttime sleep problems, sleep disorders and excessive daytime sleep. Consists of 15 items represented by a ruler (10 cm) where the patient indicates the frequency of the symptom from 0 (always)- 10 (never).
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    38 Years
    Maximum Age & Unit of Time
    78 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed with Idiopathic Parkinson's disease Mini Mental State Examination (MMSE) According to education Stages 1, 2 and 3 in the Hoehn-Yahr scale. Exclusion Criteria: Patients who have another neurological disorder associated with Parkinson's disease Cardiac with pacemaker (contraindicated the use of electrotherapy).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    NADJA ASANO, PHD
    Organizational Affiliation
    Universidade Federal de Pernambuco
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Acupuncture as Adjuvant Therapy for Sleep Disorders in Parkinson's Disease

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