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

NCT06540664 | Recruiting DMC

• 1 other identifier: 1100/HDDD-DHYD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia, Secondary; Post-stroke Depression

Keywords

insomnia

Outcome Measures

Primary Outcomes (1)

• Change sleep quality as measured by The Pittsburgh Sleep Quality Index (PSQI)

  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 Outcomes (2)

• Change number of hours slept as measured by The Pittsburgh Sleep Quality Index (PSQI)

  Baseline and Week 4

• Change the time it took participants to fall asleep as measured by The Pittsburgh Sleep Quality Index (PSQI)

  Baseline and Week 4

Study Arms (2)

Auricular Acupuncture

EXPERIMENTAL

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

Sham Auricular Acupuncture

SHAM COMPARATOR

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

Interventions

Auricular Acupuncture needles OTHER

Auricular Acupuncture needles 5 days in 2 weeks

Auricular Acupuncture

Sham Auricular Acupuncture needles OTHER

Sham Auricular Acupuncture needles 5 days in 2 weeks

Sham Auricular Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

HoChiMinh University of Medicine and Phamacy

Ho Chi Minh City, Vietnam

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

An Thi Thuy Nguyen

CONTACT

0773030312; nguyenan27011997@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 6, 2024
• Study Start: March 1, 2024
• Primary Completion: August 30, 2024
• Study Completion: October 1, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

VN (1)