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

Not Applicable

Recruiting

• Conditions: Post-stroke Depression; Insomnia, Secondary
• Interventions: Other: Auricular Acupuncture needles; Other: Sham Auricular Acupuncture needles

• Registration Number: NCT06540664
• Lead Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Study First Submitted: 2024-08-02
• Study First Submitted QC: 2024-08-02
• Study First Posted: 2024-08-06
• Primary Completion: 2024-08-30
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-26
• Last Update Posted: 2024-09-30
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Auricular Acupuncture	Auricular Acupuncture needles	Participants received Auricular Acupuncture every 5 days for 2 weeks combined with sleep hygiene, then stopped acupuncture and monitored for effectiveness after 4 weeks.
Sham Auricular Acupuncture	Sham Auricular Acupuncture needles	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.

Primary Outcome Measures

Name	Time	Method
Change sleep quality as measured by The Pittsburgh Sleep Quality Index (PSQI)	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 Outcome Measures

Name	Time	Method
Change number of hours slept as measured by The Pittsburgh Sleep Quality Index (PSQI)	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)
Change the time it took participants to fall asleep as measured by The Pittsburgh Sleep Quality Index (PSQI)	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)

Trial Locations

Locations (1)

HoChiMinh University of Medicine and Phamacy; 🇻🇳 Ho Chi Minh City, Vietnam