Acupressure to Improve Insomnia Among the Elderly With Hypertension

NCT07827560 | Recruiting DMC

• 1 other identifier: PKA2
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the feasibility and the effect of self-acupressure on improving insomnia among the elderly with hypertension who reported insomnia (using the Insomnia Severity Index questionnaire) The main questions it aims to answer are:

• Is the proposed intervention feasible to deliver to the target population in terms of recruitment, retention, adherence, and completion of outcome assessments?
• Does self-acupressure improve insomnia among the elderly with hypertension? Researchers will compare participants in the self-acupressure group (practice acupressure at home for 28 days) and the enhanced standard care group to see the effectiveness of acupressure in improving insomnia for hypertensive elderly individuals. Participants in the self-acupressure group will be instructed how to locate and perform acupressure, then they will be asked to practice acupressure at home for 28 days (once a day). Participants in the enhanced standard care group will receive training on how to apply sleep hygiene rules and will be asked to follow sleep hygiene rules for 28 days.

Conditions

Insomnia (Self-reported, Non-diagnosed); Hypertension; Elder

Keywords

acupressure; insomnia; elderly; hypertension

Outcome Measures

Primary Outcomes (1)

• Insomnia severity

  The Insomnia Severity Index (ISI) is used to measure insomnia severity among participants. This instrument had been validated translated into Vietnamese previously and was being used in the cross-sectional study with high reliability (Cronbach's α = 0.92).

  Insomnia severity will be measured at 3 time points: Baseline, Week 4, and Week 8

Secondary Outcomes (3)

• Feasibiliy outcomes

  The recruitment rate will be measured at baseline

• Feasibility outcome

  The acceptability score of the intervention will be measured at week 4

• Feasibility outcome

  Through study completion, an average of 1 year

Study Arms (2)

Acupressure group

EXPERIMENTAL

Participants will receive a self-acupressure training section and requested to practice acupressure at home once a day at night time (before going to bed) for four weeks. During that time, participants will receive a weekly phone call follow up from researchers. By the end of week fourth, participants will be requested to complete post-intervention assessment. A short-term follow up will be then carried out in 4 weeks. By the end of follow up time, participants will be asked to complete post follow up assessement and received 200.000 vnd (12 usd) as complimentary. The acupressure protocol of the intervention was developed and validated by 6 traditional and hypertensive experts.

Other: Acupressure to improve insomnia

Control group

NO INTERVENTION

Participants in the control group will receive a training session on sleep hygiene rules and will be ask to practice thoes rule in 28 days. Weekly telephone reminder will also be made in four week. By the end of week fourth, participants in this group will be requested to complete post-intervention assessment. A short-term follow up will be then carried out in 4 weeks. During the follow-up period, participants receive no weekly telephone reminder. By the end of follow up time, researchers will make a telephone reminder to participants and ask them to complete and send back all the follow-up assessment questionnaire. 200,000 vnd (equal to 12 usd) will be given to participants for complymentary

Interventions

Acupressure to improve insomnia OTHER

The acupressure protocol of the intervention was developed and validated by 6 traditional and hypertensive experts. Participants will be ask to perform acupressure with 6 acupoint including: Baihui (GV20), Yintang (GV29), Shenmen (HT\&0\< Sanyinjao (SP6), Zushalin (ST36) at nightime (30 mins before going to bed) in 28 days.Each acupoint must be stimulated in 2 mins.

Acupressure group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hypertention patient who are ≥ 60 years old
• Having Insomnia Severity Index score ≥ 11
• Having Karnofsky score ≥ 80.

You may not qualify if:

• Patients who are currently participating in clinical trials for the treatment of insomnia.
• Patients who are currently receiving pharmacological treatment for insomnia.
• Patients with concomitant cardiovascular conditions, such as heart failure; patients with an implanted pacemaker; patients who have an indication for catheter-based cardiovascular intervention; or patients who have an indication for cardiovascular surgery.
• Patients with psychiatric disorders, such as depression, generalized anxiety disorder, or bipolar disorder.

Sponsors & Collaborators

• Phenikaa University: lead

Study Sites (1)

Son Tay general hospital

Hanoi, Son Tay, 100000, Vietnam

RECRUITING

Related Publications (9)

• Zhang J, Zhou X, Jiang H, Zhu W, Chi H, Jiang L, Zhang S, Yang J, Deng S, Li B, Zhuo B, Zhang M, Cao B, Meng Z. Acupuncture for insomnia symptoms in hypertensive patients: a systematic review and meta-analysis. Front Neurol. 2024 Feb 19;15:1329132. doi: 10.3389/fneur.2024.1329132. eCollection 2024.

  PMID: 38440112 BACKGROUND

• Uchmanowicz I, Markiewicz K, Uchmanowicz B, Koltuniuk A, Rosinczuk J. The relationship between sleep disturbances and quality of life in elderly patients with hypertension. Clin Interv Aging. 2019 Jan 15;14:155-165. doi: 10.2147/CIA.S188499. eCollection 2019.

  PMID: 30697040 BACKGROUND

• Yazdanpanahi Z, Ghaemmaghami M, Akbarzadeh M, Zare N, Azisi A. Comparison of the Effects of Dry Cupping and Acupressure at Acupuncture Point (BL23) on the Women with Postpartum Low Back Pain (PLBP) Based on Short Form McGill Pain Questionnaires in Iran: A Randomized Controlled Trial. J Family Reprod Health. 2017 Jun;11(2):82-89.

  PMID: 29282415 BACKGROUND

• Wang XQ, Qin S, Wu WZ, Liu CY, Shang HT, Wan QY, Zhao YN, Xi HQ, Zheng SY, Li JH, Wang Y. [Effect of electroacupuncture on serum melatonin and dopamine in aged insomnia]. Zhongguo Zhen Jiu. 2021 May 12;41(5):501-4. doi: 10.13703/j.0255-2930.20200404-k0001. Chinese.

  PMID: 34002562 BACKGROUND

• Lu G, Chen F, Guo C, Wu J. Acupuncture for senile insomnia: A systematic review of acupuncture point. Arch Gerontol Geriatr. 2024 Dec;127:105586. doi: 10.1016/j.archger.2024.105586. Epub 2024 Jul 27.

  PMID: 39096556 BACKGROUND

• Hmwe NTT, Browne G, Mollart L, Allanson V, Chan SW. Acupressure to improve sleep quality of older people in residential aged care: a randomised controlled trial protocol. Trials. 2020 Apr 25;21(1):360. doi: 10.1186/s13063-020-04286-2.

  PMID: 32334620 BACKGROUND

• Yao L, Liu Y, Li M, Zheng H, Sun M, He M, Zhong Z, Ma S, Huang H, Wang H. The central regulatory effects of acupuncture in treating primary insomnia: a review. Front Neurol. 2024 Dec 10;15:1406485. doi: 10.3389/fneur.2024.1406485. eCollection 2024.

  PMID: 39719980 BACKGROUND

• Wang Y, Jiang HL, Zhao JY, Liu NN, Yi L, Yang ZR, Zhao SM, Wang FC. Efficacy of multiple acupoint stimulation therapies for primary insomnia patients: a systematic review and network meta-analysis. Front Psychiatry. 2026 Apr 13;17:1678631. doi: 10.3389/fpsyt.2026.1678631. eCollection 2026.

  PMID: 42052531 BACKGROUND

• Yu XS, Liu YM, Pan W, Wang XY, Lin LN, Shen QY, Zhang H, Zheng SY, Nie N, Jin B, Liang Y, Liu YJ, Fang JQ. Acupoint Sensitivity in Patients with Primary Insomnia and Its Correlation with Polysomnography and Heart Rate Variability: A Cross-Sectional Study. Nat Sci Sleep. 2026 Mar 4;18:567428. doi: 10.2147/NSS.S567428. eCollection 2026.

  PMID: 41809063 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Hypertension

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Huong Hoang, PhD

CONTACT

+84 0982501850; huong.hoangthixuan@phenikaa-uni.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Nursing and Midwifery Faculty

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 18, 2026
• Study Start: August 30, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)