Clincosm LogoSign in Get a demo

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

Sponsor
Universidade Federal de Pernambuco (Other)
Overall Status
Completed
CT.gov ID
NCT02731677
Collaborator
(none)
22
Enrollment
2
Arms
3
Duration (Months)

Study Details

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.
Condition or Disease Intervention/Treatment Phase
  • Other: Acupuncture
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Acupuncture as Adjuvant Therapy for Sleep Disorders in Parkinson's Disease
Study Start Date :
Nov 1, 2015
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental

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.

Other: Acupuncture
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.
No Intervention: Control

The control group no suffered intervention.

Outcome Measures

Primary Outcome Measures

  1. Scale for Parkinson's disease (PDSS) [8 weeks]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
38 Years to 78 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Universidade Federal de Pernambuco

Investigators

  • Principal Investigator: NADJA ASANO, PHD, Universidade Federal de Pernambuco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NADJA MARIA JORGE ASANO, PRINCIPAL INVESTIGATOR, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier:
NCT02731677
Other Study ID Numbers:
  • CAAE 49662915.4.0000.5208
First Posted:
Apr 7, 2016
Last Update Posted:
Apr 7, 2016
Last Verified:
Apr 1, 2016
Additional relevant MeSH terms:
Parkinson Disease
Sleep Wake Disorders
Parasomnias

Study Results

No Results Posted as of Apr 7, 2016