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NCT Number: NCT06540664

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

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.

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Key information

Conditions

Insomnia, Secondary Dyssomnias Mental Disorders Nervous System Diseases Post-stroke Depression Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HoChiMinh University of Medicine and Phamacy

Ho Chi Minh City, Vietnam

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auricular Acupuncture needles

Other

Auricular Acupuncture needles 5 days in 2 weeks

Sham Auricular Acupuncture needles

Other

Sham Auricular Acupuncture needles 5 days in 2 weeks

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

An Thi Thuy Nguyen

CONTACT

[email protected]

0773030312

Sponsors and collaborators

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 6, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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