Insomnia (Self-reported, Non-diagnosed)NCT07827560
Acupressure to Improve Insomnia Among the Elderly With Hypertension
A study testing Acupressure to improve insomnia in people with Insomnia (Self-reported, Non-diagnosed) and Hypertension, run by Phenikaa University at 1 site in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Insomnia (Self-reported, Non-diagnosed), Hypertension, Elder
- What is being tested?
- Acupressure to improve insomnia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteVietnam
- Study dates
- 30 Aug 2026to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertention patient who are ≥ 60 years old
- Having Insomnia Severity Index score ≥ 11
- Having Karnofsky score ≥ 80.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Son Tay general hospital
Hanoi, Son Tay, 100000
Huong Hoang, +84 0982501850, huong.hoangthixuan@phenikaa-uni.edu.vn
About this study
Official title: Self-acupressure to Improve Insomnia Among the Elderly With Hypertension: a Randomized Controlled Trial
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:
Read more
- 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
- Being tested
- Acupressure to improve insomnia
- Keywords
- acupressure, insomnia, elderly, hypertension
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupressure to improve insomniaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 calculated based on the number of screened patients, the number of eligible patients, the number of eligible patients who finally agree to participate in the study, the number of patients who sign the informed consent form, the reasons for ineligibility and refusal, and the time to recruit enough participants will be recorded.
Measured: The recruitment rate will be measured at baseline
Feasibility outcome
- The acceptability score of the intervention will be measured by the Intervention Rating Profile (IRP-15), which consists of 15 Likert-type items; the sum of all 15 items ranges from 15 to 90. Higher overall scores indicate greater acceptability. A cutoff mean score (or average item score above 4.0) generally denotes that an intervention is perceived as acceptable and practical
Measured: The acceptability score of the intervention will be measured at week 4
Feasibility outcome
The attrition rate will be calculated by the number of participants who decide to discontinue the study and the number of participants who are lost to follow-up during the study period. The attrition rate ranges from 0% to 100%, the higher lower attrition rate indicate the better feasible study is.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start30 Aug 2026
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Insomnia (Self-reported, Non-diagnosed)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phenikaa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoang T.X Huong, Phenikaa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827560
- Sponsor's protocol ID
- PKA2
- Status last verified
- Oct 2026
- First submitted
- 27 Aug 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38440112Uchmanowicz 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.
PubMed 30697040Yazdanpanahi 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.
PubMed 29282415Wang 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.
PubMed 34002562Lu 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.
PubMed 39096556Hmwe 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.
PubMed 32334620Yao 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.
PubMed 39719980Wang 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.
PubMed 42052531Yu 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.
PubMed 41809063
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-acupressure to Improve Insomnia Among the Elderly With Hypertension: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07827560
- Acronym / sponsor ID
- PKA2
- Conditions
- Insomnia (Self-reported, Non-diagnosed), Hypertension, Elder
- Keywords
- acupressure, insomnia, elderly, hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Phenikaa UniversityUniversity, hospital or other
- Study start
- 30 Aug 2026 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 18 Sep 2026 (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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupressure group | Experimental | Other: Acupressure to improve insomniaParticipants 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. |
| 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hypertention patient who are ≥ 60 years old
- Having Insomnia Severity Index score ≥ 11
- Having Karnofsky score ≥ 80.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Acupressure to improve insomniaThe 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. | Other | Acupressure group |
Primary outcome
Insomnia severity
Time frame: Insomnia severity will be measured at 3 time points: Baseline, Week 4, and Week 8
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).
3 secondary outcomes
Feasibiliy outcomes
Time frame: The recruitment rate will be measured at baseline
Feasibility outcome
Time frame: The acceptability score of the intervention will be measured at week 4
Feasibility outcome
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 38440112Zhang 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.
- Background: PubMed 30697040Uchmanowicz 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.
- Background: PubMed 29282415Yazdanpanahi 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.
- Background: PubMed 34002562Wang 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.
- Background: PubMed 39096556Lu 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.
- Background: PubMed 32334620Hmwe 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.
- Background: PubMed 39719980Yao 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.
- Background: PubMed 42052531Wang 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.
- Background: PubMed 41809063Yu 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.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure to improve insomnia in people with Insomnia (Self-reported, Non-diagnosed) and Hypertension, run by Phenikaa University 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 3 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huong Hoang, PhD (+84 0982501850, huong.hoangthixuan@phenikaa-uni.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia severity (time frame: Insomnia severity will be measured at 3 time points: Baseline, Week 4, and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07827560, which also lists 9 linked publications.
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 2 Oct 2026.