Insomnia ChronicAAHDINNCT03015766

Auricular Acupressure for Hemodialysis Patients With Insomnia

A study testing auricular acupressure therapy in people with Insomnia Chronic, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 6 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Auricular acupressure therapy (AAT) has been applied in MHD patients with insomnia in recent years and yielded favorable results. However, the effect and safety of AAT for insomnia in MHD population still lacks high quality evidence. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Insomnia Chronic
What is being tested?: auricular acupressure therapy
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 130 participants
Where: 6 sitesChina
Study dates: 1 May 2017to 1 May 2019
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged 18~75 years
On regular dialysis ( 2 - 3 sessions weekly, 4 hours each session, total weekly dialysis hours ≥ 10 hours) for more than 3 months (but less than 10 years)
Insomnia according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
Global score of PSQI > 7
Informed consent.

Who cannot join

Presence of co-morbidities including cancer, congestive heart failure, connective tissue disease and hematologic diseases;
Inadequately dialyzed, indicating by urea clearance index (KT/V) < 1.20;
Presence of severe physical symptoms such as bone pain, itchy skin, sleep apnea and restless legs which are obviously causative for insomnia; and weary condition caused by severe anemia (hemoglobin<60g/L) or malnutrition (serum albumin<30g/L).
Infections of external ears or malformed ears.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

China6 sites

Guangzhou HEMC (Higher Education Mega Center) Hospital
Guangzhou, Guangdong, 510000
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510120
Guangzhou Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510130
Guangzhou Charity Hospital
Guangzhou, Guangdong, 510370
Wuyi Hospital of Traditional Chinese Medicine
Jiangsu Sheng, Guangdong, 529099
Shenzhen Hospital of Traditional Chinese Medicine
Shebu, Guangdong, 518026

Other trials in China

About this study

Official title: Auricular Acupressure for Hemodialysis Patients With Insomnia: Study Protocol for a Multi-centre Double-blind, Randomized Controlled Trial

Read the detailed description

Insomnia, a worldwide health problem, is much more frequently complained in maintenance hemodialysis (MHD) patients and impairs their quality of life and long term outcome. Hypnotic sedative agents are often reluctantly prescribed with doses mounting up. Patients are concerned about drug dependence and drug-related adverse effects. As a non-drug therapy, auricular acupressure therapy (AAT) is attractive to both patients and practitioners and is widely used to treat many conditions in China. The investigators had been applying AAT for MHD patients with insomnia in recent years and yielded favorable results. However, the effect and safety of AAT for insomnia in MHD population still lacks high quality evidence. Therefore, the investigators aimed to perform a randomized controlled clinical trial in MHD patients with insomnia to evaluate the effect and safety of AAT.

Conditions: Insomnia Chronic
Being tested: auricular acupressure therapy, sham auricular acupressure therapy
Keywords: insomnia, hemodialysis, auricular acupressure, randomized controlled trial
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 acupressure therapyOther
Also called auricular acupressure, ear acupressure
Auricular acupressure, is a therapeutic method in which specific acupoints on the ear are stimulated to treat various disorders of the body. This practice is based on the theory that there are specific points on the auricle which correspond to major organs or systems of the body; and therapeutic effect on the corresponding target organ or system can be exerted by manipulating auricular acupoints. Auricular acupressure applies stimulation through pressure on specific acupoints by the imbedded beads, usually Semen Vaccaria (Wang Bu Liu Xing) or stainless steel beads. This therapeutic method is non-invasive and can be self-manipulated by the recipients at times required.
sham auricular acupressure therapyOther
Also called sham AAT
The intervention is the same as that in the experimental group only when the points are five Helix points (HX 5-9). These points are clearly remote from the inner ear area and have no evidence for insomnia treatment.

Study groups in NCT03015766
Study group	Role	What they receive
Auricular acupressure therapy	Experimental	Participants in the treatment group will received AAT on five active acupoints including Acup.1. Shen Men (Spiritual Gate, TF4), Acup.2. Jiao Gan (Sympathetic autonomic, AH6a), Acup.3. Xin (Heart, CO15), Acup.4. Pi Zhi Xia (Subcortex, AT4), Acup.5. Nei Fen Mi (Endocrine, CO18) Receives: Other: auricular acupressure therapy
sham auricular acupressure therapy	Sham comparator	Participants in the control group (SAA group) will receive auricular acupressure on five Helix points (HX 5-9), which were clearly remote from the inner ear area. These points have no evidence for insomnia management. Receives: Other: sham auricular acupressure therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

clinical response rate
Response is defined as a reduction of Pittsburgh sleep quality index (PSQI) global score by 3 points and more according to literature review
Measured: at 8 weeks from baseline

Secondary outcomes (6)

change of PSQI scores at the end of treatment
PSQI scores will include PSQI global score, and scores of each domain (i.e. sleep duration, sleep disturbance, sleep latency, day dysfunction, sleep efficiency, overall sleep quality and sleep medication).
Measured: change from baseline PSQI scores at 8 weeks
change of PSQI scores at the first followup
PSQI scores will include PSQI global score, and scores of each domain (i.e. sleep duration, sleep disturbance, sleep latency, day dysfunction, sleep efficiency, overall sleep quality and sleep medication).
Measured: change from baseline PSQI scores at 12 weeks
change of PSQI scores at the second followup
PSQI scores will include PSQI global score, and scores of each domain (i.e. sleep duration, sleep disturbance, sleep latency, day dysfunction, sleep efficiency, overall sleep quality and sleep medication).
Measured: change from baseline PSQI scores at 16 weeks
change of PSQI scores at the third followup
PSQI scores will include PSQI global score, and scores of each domain (i.e. sleep duration, sleep disturbance, sleep latency, day dysfunction, sleep efficiency, overall sleep quality and sleep medication).
Measured: change from baseline PSQI scores at 20 weeks
weekly dose of hypnotics
If participants required hypnotic agents during the study because of unbearable sleep disorders, they will be allowed to take hypnotics initiating from the minimum dose and encouraged to complete the trial. The weekly dose of hypnotic agents will be recorded.
Measured: Day 0 (baseline), at 8 weeks (the end of treatment), at 12 weeks (the first followup),at 16 weeks (the second followup) and at 20 weeks (the third followup)
adverse events
Adverse events throughout the treatment and follow-up periods, regardless of its relevance to the interventions, will be documented and dealt with by appropriate measures.
Measured: through study completion, an average of 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20171 May 2019

First posted10 Jan 2017 (estimated)
Study start1 May 2017
Primary completion1 Oct 2018
Study completion1 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Insomnia ChronicStudies 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: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03015766
Sponsor's protocol ID: YN2015MS25
Acronym: AAHDIN
Status last verified: May 2019
First submitted: 22 Dec 2016
Last updated: 13 May 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD including the demographic information, PSQI scores and drug use at baseline and 8,12,16,20 week from baseline of all participants will be shared. The data will be availbale at ResMan® Clinical Trial Management Public Platform, with the link http://www.medresman.org/uc/index.aspx

Publications

Zou C, Yang L, Wu Y, Su G, Chen S, Guo X, Wu X, Liu X, Lin Q. Auricular acupressure on specific points for hemodialysis patients with insomnia: a pilot randomized controlled trial. PLoS One. 2015 Apr 15;10(4):e0122724. doi: 10.1371/journal.pone.0122724. eCollection 2015.
PubMed 25874938
Wu Y, Zou C, Liu X, Wu X, Lin Q. Auricular acupressure helps improve sleep quality for severe insomnia in maintenance hemodialysis patients: a pilot study. J Altern Complement Med. 2014 May;20(5):356-63. doi: 10.1089/acm.2013.0319. Epub 2014 Feb 26.
PubMed 24571603
Wu Y, Yang L, Zhong Z, Wu X, He Z, Ma H, Cai C, Li Y, Wu X, Fu B, Chen X, Wang L, Zhao D, Meng X, Qi A, Yang A, Li L, Liu X, Zou C, Lin Q. Auricular Acupressure for Hemodialysis Patients with Insomnia: A Multicenter Double-Blind Randomized Sham-Controlled Trial. J Integr Complement Med. 2022 Apr;28(4):339-348. doi: 10.1089/jicm.2021.0332. Epub 2022 Jan 13.
PubMed 35426736
Wu Y, Yang L, Li L, Wu X, Zhong Z, He Z, Ma H, Wang L, Lu Z, Cai C, Zhao D, Meng X, Qi A, Yang A, Su G, Guo X, Liu X, Zou C, Lin Q. Auricular acupressure for insomnia in hemodialysis patients: study protocol for a randomized controlled trial. Trials. 2018 Mar 7;19(1):171. doi: 10.1186/s13063-018-2546-2.
PubMed 29514705

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Insomnia Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Auricular Acupressure for Hemodialysis Patients With Insomnia: Study Protocol for a Multi-centre Double-blind, Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03015766
Acronym / sponsor ID: AAHDIN / YN2015MS25
Conditions: Insomnia Chronic
Keywords: insomnia, hemodialysis, auricular acupressure, randomized controlled trial
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese MedicineUniversity, hospital or other
Study start: 1 May 2017 (actual)
Primary completion: 1 Oct 2018 (actual)
Study completion: 1 May 2019 (actual)
First posted: 10 Jan 2017 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Auricular acupressure therapy	Experimental	Other: auricular acupressure therapyParticipants in the treatment group will received AAT on five active acupoints including Acup.1. Shen Men (Spiritual Gate, TF4), Acup.2. Jiao Gan (Sympathetic autonomic, AH6a), Acup.3. Xin (Heart, CO15), Acup.4. Pi Zhi Xia (Subcortex, AT4), Acup.5. Nei Fen Mi (Endocrine, CO18)
sham auricular acupressure therapy	Sham comparator	Other: sham auricular acupressure therapyParticipants in the control group (SAA group) will receive auricular acupressure on five Helix points (HX 5-9), which were clearly remote from the inner ear area. These points have no evidence for insomnia management.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Aged 18~75 years
On regular dialysis ( 2 - 3 sessions weekly, 4 hours each session, total weekly dialysis hours ≥ 10 hours) for more than 3 months (but less than 10 years)
Insomnia according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
Global score of PSQI > 7
Informed consent.

Key exclusion criteria (4 listed)

Presence of co-morbidities including cancer, congestive heart failure, connective tissue disease and hematologic diseases;
Inadequately dialyzed, indicating by urea clearance index (KT/V) < 1.20;
Presence of severe physical symptoms such as bone pain, itchy skin, sleep apnea and restless legs which are obviously causative for insomnia; and weary condition caused by severe anemia (hemoglobin<60g/L) or malnutrition (serum albumin<30g/L).
Infections of external ears or malformed ears.

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 acupressure therapyAlso: auricular acupressure, ear acupressureAuricular acupressure, is a therapeutic method in which specific acupoints on the ear are stimulated to treat various disorders of the body. This practice is based on the theory that there are specific points on the auricle which correspond to major organs or systems of the body; and therapeutic effect on the corresponding target organ or system can be exerted by manipulating auricular acupoints. Auricular acupressure applies stimulation through pressure on specific acupoints by the imbedded beads, usually Semen Vaccaria (Wang Bu Liu Xing) or stainless steel beads. This therapeutic method is non-invasive and can be self-manipulated by the recipients at times required.	Other	Auricular acupressure therapy
sham auricular acupressure therapyAlso: sham AATThe intervention is the same as that in the experimental group only when the points are five Helix points (HX 5-9). These points are clearly remote from the inner ear area and have no evidence for insomnia treatment.	Other	sham auricular acupressure therapy

Primary outcome

clinical response rate
Time frame: at 8 weeks from baseline
Response is defined as a reduction of Pittsburgh sleep quality index (PSQI) global score by 3 points and more according to literature review

6 secondary outcomes

change of PSQI scores at the end of treatment
Time frame: change from baseline PSQI scores at 8 weeks
change of PSQI scores at the first followup
Time frame: change from baseline PSQI scores at 12 weeks
change of PSQI scores at the second followup
Time frame: change from baseline PSQI scores at 16 weeks
change of PSQI scores at the third followup
Time frame: change from baseline PSQI scores at 20 weeks
weekly dose of hypnotics
Time frame: Day 0 (baseline), at 8 weeks (the end of treatment), at 12 weeks (the first followup),at 16 weeks (the second followup) and at 20 weeks (the third followup)
adverse events
Time frame: through study completion, an average of 20 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
Results publication: PubMed 25874938Zou C, Yang L, Wu Y, Su G, Chen S, Guo X, Wu X, Liu X, Lin Q. Auricular acupressure on specific points for hemodialysis patients with insomnia: a pilot randomized controlled trial. PLoS One. 2015 Apr 15;10(4):e0122724. doi: 10.1371/journal.pone.0122724. eCollection 2015.
Results publication: PubMed 24571603Wu Y, Zou C, Liu X, Wu X, Lin Q. Auricular acupressure helps improve sleep quality for severe insomnia in maintenance hemodialysis patients: a pilot study. J Altern Complement Med. 2014 May;20(5):356-63. doi: 10.1089/acm.2013.0319. Epub 2014 Feb 26.
Derived from this study: PubMed 35426736Wu Y, Yang L, Zhong Z, Wu X, He Z, Ma H, Cai C, Li Y, Wu X, Fu B, Chen X, Wang L, Zhao D, Meng X, Qi A, Yang A, Li L, Liu X, Zou C, Lin Q. Auricular Acupressure for Hemodialysis Patients with Insomnia: A Multicenter Double-Blind Randomized Sham-Controlled Trial. J Integr Complement Med. 2022 Apr;28(4):339-348. doi: 10.1089/jicm.2021.0332. Epub 2022 Jan 13.
Derived from this study: PubMed 29514705Wu Y, Yang L, Li L, Wu X, Zhong Z, He Z, Ma H, Wang L, Lu Z, Cai C, Zhao D, Meng X, Qi A, Yang A, Su G, Guo X, Liu X, Zou C, Lin Q. Auricular acupressure for insomnia in hemodialysis patients: study protocol for a randomized controlled trial. Trials. 2018 Mar 7;19(1):171. doi: 10.1186/s13063-018-2546-2.
previously finished pilot RCTLink provided by the sponsor.
observational study on auricular acupressureLink provided by the sponsor.
Individual participant dataSharing planned: Yes. IPD including the demographic information, PSQI scores and drug use at baseline and 8,12,16,20 week from baseline of all participants will be shared. The data will be availbale at ResMan® Clinical Trial Management Public Platform, with the link http://www.medresman.org/uc/index.aspx

Related trials for Insomnia Chronic

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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.

Qizhan Lin, MD principal investigator

Guangdong Provincial Hospital of Traditional Chinese Medicine

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing auricular acupressure therapy in people with Insomnia Chronic, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 6 sites in China.

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 5 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: finished, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

clinical response rate (time frame: at 8 weeks from baseline). 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 NCT03015766, which also lists 4 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 13 May 2019.