Efficacy and Safety of Auricular Acupuncture in Treating Insomnia Post-stroke

September 26, 2024 updated by: NGUYEN THI THUY AN, University of Medicine and Pharmacy at Ho Chi Minh City

Evaluating Efficacy and Safety of Auricular Acupuncture in Treating Insomnia Post-stroke: A Randomized Controlled Trial

The goal of this clinical trial is to learn if Auricular acupuncture works to treat Insomnia Post-stroke patients. It will also learn about the safety of Auricular. The main questions it aims to answer are:

  • Does Auricular acupuncture reduce the time it took participants to fall asleep?
  • Dose Auricular acupuncture increase the number of hours participants slept?
  • Dose Auricular acupuncture improve sleep quality as measured by The Pittsburgh Sleep Quality Index (PSQI)?
  • What medical problems do participants have when taking Auricular acupuncture? Researchers will compare Auricular acupuncture to a sham Auricular acupuncture (a look-alike acupuncture needles that contains no needles) to see if Auricular acupuncture works to treat insomnia post-stroke.

Participants will:

  • Take Auricular acupuncture or sham Auricular acupuncture every 5 days for 4 weeks.
  • Checkups and evaluate sleep onset time, sleep hours, and sleep quality every 5 days for 4 weeks.
  • Keep a diary sleep of their symptoms and the number of times they use sleeping pills.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam
        • Recruiting
        • HoChiMinh University of Medicine and Phamacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18 years or older, with a post-stroke period of 03 months or more, based on discharge papers or medical records.
  • Patients who meet the diagnostic criteria for insomnia according to the DSM-V of the American Psychiatric Association for at least 3 months.

Exclusion Criteria:

  • Patients with insomnia before the stroke.
  • Patients diagnosed with other sleep disorders such as sleep apnea syndrome, narcolepsy.
  • Patients diagnosed with neurological diseases or psychiatric disorders such as: Anxiety disorders, autism spectrum disorders, depression, obsessive-compulsive disorder, behavioral disorders affecting sleep before the stroke.
  • Patients are using antidepressants, psychiatric drugs.
  • Patients participating in other clinical trials with behavioral, psychological or complementary medical interventions during the study period.
  • Patients not cooperating during data collection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Auricular Acupuncture
Participants received Auricular Acupuncture every 5 days for 2 weeks combined with sleep hygiene, then stopped acupuncture and monitored for effectiveness after 4 weeks.
Other: Auricular Acupuncture needles
Auricular Acupuncture needles 5 days in 2 weeks
Sham Comparator: Sham Auricular Acupuncture
Participants received sham Auricular Acupuncture every 5 days for 2 weeks combined with sleep hygiene, then stopped acupuncture and monitored for effectiveness after 4 weeks.
Other: Sham Auricular Acupuncture needles
Sham Auricular Acupuncture needles 5 days in 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change sleep quality as measured by The Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline and Week 4
The Pittsburgh Sleep Quality Index (PSQI) is a validated, self-reported instrument assessing sleep quality over 1 month. Possible scores range from 0 to 21. PSQI < 5 (good sleep quality), PSQI >5 (poor sleep quality)
Baseline and Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change number of hours slept as measured by The Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline and Week 4
The Pittsburgh Sleep Quality Index (PSQI) is a validated, self-reported instrument assessing sleep quality over 1 month. The score of hours slept range 0 (hours of sleep > 7 hours) to 3 (Hours of sleep < 4 hours)
Baseline and Week 4
Change the time it took participants to fall asleep as measured by The Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline and Week 4
The Pittsburgh Sleep Quality Index (PSQI) is a validated, self-reported instrument assessing sleep quality over 1 month. The score of time it took participants to fall asleep range 0 (<15 minutes) to 3 ( >60 minutes)
Baseline and Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

August 30, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

August 2, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 26, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1100/HDDD-DHYD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post-stroke Depression

Clinical Trials on Auricular Acupuncture needles

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe