Therapeutic Effect of Self-administered Auricular Acupressure on Insomnia Induced by Anxiety

Insomnia Due to Anxiety and Fear Clinical Trial

Official title:

Therapeutic Effect of Self-administered Auricular Acupressure on Insomnia Induced by Anxiety: A Randomized Sham-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05152095
• Other study ID #: BCM I-2021 (04)
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: December 2021
• Source: International Medical University
• Contact: Ms Tang
• Phone: 03-27317202
• Email: freyatang[@]imu.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: January 31, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Insomnia Due to Anxiety and Fear
• Sleep Initiation and Maintenance Disorders

Intervention

Other:
• Vaccaria seed (Wang Bu Liu Xing) pre-attached to adhesive tape used for auricular acupressure
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 tape
Apply on Shenmen and Occiput without applying pressure for 5 days.

Locations

Country	Name	City	State
Malaysia	International Medical University (IMU)	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
International Medical University

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6th day
Primary	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)	11th day
Primary	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.	6th day
Primary	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.	11th day