Insomnia, SecondaryNCT06540664
Efficacy and Safety of Auricular Acupuncture in Treating Insomnia Post-stroke
A study testing Auricular Acupuncture needles in people with Insomnia, Secondary and Post-stroke Depression, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Secondary, Post-stroke Depression
- What is being tested?
- Auricular Acupuncture needles
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Mar 2024to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
HoChiMinh University of Medicine and Phamacy
Ho Chi Minh City
About this study
Official title: 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.
Read more
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
- Being tested
- Auricular Acupuncture needles, Sham Auricular Acupuncture needles
- Keywords
- insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular Acupuncture needlesOther
Auricular Acupuncture needles 5 days in 2 weeks
Sham Auricular Acupuncture needlesOther
Sham Auricular Acupuncture needles 5 days in 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham Auricular Acupuncture needles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and Week 4
Secondary outcomes (2)
Change number of hours slept 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. The score of hours slept range 0 (hours of sleep > 7 hours) to 3 (Hours of sleep < 4 hours)
Measured: Baseline and Week 4
Change the time it took participants to fall asleep 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. The score of time it took participants to fall asleep range 0 (<15 minutes) to 3 ( >60 minutes)
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Mar 2024
- Primary completion30 Aug 2024
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia, SecondaryStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NGUYEN THI THUY AN, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540664
- Sponsor's protocol ID
- 1100/HDDD-DHYD
- Status last verified
- Sep 2024
- First submitted
- 2 Aug 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Efficacy and Safety of Auricular Acupuncture in Treating Insomnia Post-stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06540664
- Acronym / sponsor ID
- 1100/HDDD-DHYD
- Conditions
- Insomnia, Secondary, Post-stroke Depression
- Keywords
- insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- Oct 2024 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular Acupuncture | Experimental | Other: Auricular Acupuncture needlesParticipants 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 comparator | Other: Sham Auricular Acupuncture needlesParticipants received sham Auricular Acupuncture every 5 days for 2 weeks combined with sleep hygiene, then stopped acupuncture and monitored for effectiveness after 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular Acupuncture needlesAuricular Acupuncture needles 5 days in 2 weeks | Other | Auricular Acupuncture |
| Sham Auricular Acupuncture needlesSham Auricular Acupuncture needles 5 days in 2 weeks | Other | Sham Auricular Acupuncture |
Primary outcome
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)
2 secondary outcomes
Change number of hours slept as measured by The Pittsburgh Sleep Quality Index (PSQI)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Acupuncture needles in people with Insomnia, Secondary and Post-stroke Depression, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact An Thi Thuy Nguyen (0773030312, nguyenan27011997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change sleep quality as measured by The Pittsburgh Sleep Quality Index (PSQI) (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.