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

NCT ID: NCT06540664

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Insomnia, Secondary Post-stroke Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Auricular Acupuncture needles

Intervention Type OTHER

Auricular Acupuncture needles 5 days in 2 weeks

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.

Group Type SHAM_COMPARATOR

Sham Auricular Acupuncture needles

Intervention Type OTHER

Sham Auricular Acupuncture needles 5 days in 2 weeks

Interventions

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Auricular Acupuncture needles

Auricular Acupuncture needles 5 days in 2 weeks

Intervention Type OTHER

Sham Auricular Acupuncture needles

Sham Auricular Acupuncture needles 5 days in 2 weeks

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Medicine and Pharmacy at Ho Chi Minh City

OTHER

Sponsor Role lead

Responsible Party

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NGUYEN THI THUY AN

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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HoChiMinh University of Medicine and Phamacy

Ho Chi Minh City, , Vietnam

Site Status RECRUITING

Countries

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Vietnam

Central Contacts

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An Thi Thuy Nguyen

Role: CONTACT

0773030312

Other Identifiers

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1100/HDDD-DHYD

Identifier Type: -

Identifier Source: org_study_id

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