Insomnia Due to Anxiety and FearNCT05152095
Therapeutic Effect of Self-administered Auricular Acupressure on Insomnia Induced by Anxiety
A study testing Vaccaria seed (Wang Bu Liu Xing) pre-attached to adhesive tape used for auricular acupressure and Plain ear adhesive tape in people with Insomnia Due to Anxiety and Fear, run by IMU University, Malaysia at 1 site in Malaysia.
Trial summary
This is a sham-controlled randomized trial to identify the effectiveness of treating insomnia induced by anxiety with self-administered auricular acupressure in Malaysia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia Due to Anxiety and Fear
- What is being tested?
- Vaccaria seed (Wang Bu Liu Xing) pre-attached to adhesive tape used for auricular acupressure and Plain ear adhesive tape
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteMalaysia
- Study dates
- 13 Nov 2021to 31 Jan 2022
- 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
- All Malaysian aged above 18 years old who are suffering from chronic insomnia based on International Classification of Sleep Disorders 3(ICSD-3) and with Insomnia Severity Index (ISI) of 18 and above and more than 3 months.
- Willing to comply with the recommended periodic acupressure stimulation every day during the 1 week period.
Who cannot join
- Subject with insomnia score below 18 based on Insomnia Severity Index (ISI).
- Subject with stress and anxiety level below 18 in the Hamilton Anxiety Rating Scale (HAM-A).
- Subject with the history of skin sensitivity.
- Subject who just started on new medication to treat insomnia.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
International Medical University (IMU)
Kuala Lumpur
Ms Tang, 03-27317202
About this study
Official title: Therapeutic Effect of Self-administered Auricular Acupressure on Insomnia Induced by Anxiety: A Randomized Sham-controlled Trial
This is a sham-controlled randomized trial to identify the effectiveness of treating insomnia induced by anxiety with self-administered auricular acupressure in Malaysia.
Read the detailed description
112 subjects with insomnia and anxiety who fit to the inclusion and exclusion criteria will be recruited into the trial. After initial screening, subjects will be randomly allocated to Vaccaria seed tapes (experimental arm) or non-Varracia seed plain tapes (sham comparator arm).
On the sixth day for the trial (after 5 days of daily auricular acupressure), the ISI and HAM-A score of subjects will be reassessed again. The subjects have to stop applying auricular acupressure for the next five days and reassess their ISI and HAM-A score again on the eleventh day.
- Conditions
- Insomnia Due to Anxiety and Fear
- Being tested
- Vaccaria seed (Wang Bu Liu Xing) pre-attached to adhesive tape used for auricular acupressure, Plain ear adhesive tape
- Keywords
- auricular acupressure, insomnia, anxiety, randomized sham controlled trial
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccaria seed (Wang Bu Liu Xing) pre-attached to adhesive tape used for auricular acupressureOther
Apply on auricular acupoints, Shenmen and Occiput, apply pressure for 3 minutes, 5 times per day, at the interval of 2 ~ 3 hours, for 5 days.
Plain ear adhesive tapeOther
Apply on Shenmen and Occiput without applying pressure for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Self-administered Vaccaria seed tapes on auricular acupoints with pressure applied Receives: Other: Vaccaria seed (Wang Bu Liu Xing) pre-attached to adhesive tape used for auricular acupressure |
| Sham | Sham comparator | Self-administered plain tapes (without Vaccaria seed) on auricular acupoints without applying pressure. Receives: Other: Plain ear adhesive tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
Total score categories:
0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
Measured: 6th day
Insomnia Severity Index (ISI)
Total score categories:
0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
Measured: 11th day
Hamilton Anxiety Rating Scale (HAM-A)
Total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Measured: 6th day
Hamilton Anxiety Rating Scale (HAM-A)
Total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Measured: 11th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start13 Nov 2021
- Primary completion1 Jan 2022 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia Due to Anxiety and FearStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IMU University, Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tang Sin Wei, IMU University, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152095
- Sponsor's protocol ID
- BCM I-2021 (04)
- Status last verified
- Dec 2021
- First submitted
- 1 Dec 2021
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Self-administered Auricular Acupressure on Insomnia Induced by Anxiety: A Randomized Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT05152095
- Acronym / sponsor ID
- BCM I-2021 (04)
- Conditions
- Insomnia Due to Anxiety and Fear
- Keywords
- auricular acupressure, insomnia, anxiety, randomized sham controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- IMU University, MalaysiaUniversity, hospital or other
- Study start
- 13 Nov 2021 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 9 Dec 2021 (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.
This is a sham-controlled randomized trial to identify the effectiveness of treating insomnia induced by anxiety with self-administered auricular acupressure in Malaysia.
Detailed description
112 subjects with insomnia and anxiety who fit to the inclusion and exclusion criteria will be recruited into the trial. After initial screening, subjects will be randomly allocated to Vaccaria seed tapes (experimental arm) or non-Varracia seed plain tapes (sham comparator arm).
On the sixth day for the trial (after 5 days of daily auricular acupressure), the ISI and HAM-A score of subjects will be reassessed again. The subjects have to stop applying auricular acupressure for the next five days and reassess their ISI and HAM-A score again on the eleventh day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Vaccaria seed (Wang Bu Liu Xing) pre-attached to adhesive tape used for auricular acupressureSelf-administered Vaccaria seed tapes on auricular acupoints with pressure applied |
| Sham | Sham comparator | Other: Plain ear adhesive tapeSelf-administered plain tapes (without Vaccaria seed) on auricular acupoints without applying pressure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All Malaysian aged above 18 years old who are suffering from chronic insomnia based on International Classification of Sleep Disorders 3(ICSD-3) and with Insomnia Severity Index (ISI) of 18 and above and more than 3 months.
- Willing to comply with the recommended periodic acupressure stimulation every day during the 1 week period.
Key exclusion criteria (4 listed)
- Subject with insomnia score below 18 based on Insomnia Severity Index (ISI).
- Subject with stress and anxiety level below 18 in the Hamilton Anxiety Rating Scale (HAM-A).
- Subject with the history of skin sensitivity.
- Subject who just started on new medication to treat insomnia.
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 |
|---|---|---|
| Vaccaria seed (Wang Bu Liu Xing) pre-attached to adhesive tape used for auricular acupressureApply on auricular acupoints, Shenmen and Occiput, apply pressure for 3 minutes, 5 times per day, at the interval of 2 ~ 3 hours, for 5 days. | Other | Intervention |
| Plain ear adhesive tapeApply on Shenmen and Occiput without applying pressure for 5 days. | Other | Sham |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: 6th day
Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
Insomnia Severity Index (ISI)
Time frame: 11th day
Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: 6th day
Total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: 11th day
Total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
- Individual participant dataSharing planned: No
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Chronic Insomnia, Sleep Deprivation
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 Vaccaria seed (Wang Bu Liu Xing) pre-attached to adhesive tape used for auricular acupressure and Plain ear adhesive tape in people with Insomnia Due to Anxiety and Fear, run by IMU University, Malaysia at 1 site in Malaysia.
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 4 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 30 Dec 2021. 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 Malaysia. 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 Ms Tang (03-27317202, freyatang@imu.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: 6th day). The study lists 4 primary outcomes in all. 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 30 Dec 2021.