Auricular Acupressure for Hemodialysis Patients With Insomnia
- Conditions
- Insomnia Chronic
- Interventions
- Other: sham auricular acupressure therapyOther: auricular acupressure therapy
- Registration Number
- NCT03015766
- Lead Sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Brief 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. A randomized controlled clinical trial is planned to evaluate the effect and safety of AAT in MHD patients with insomnia.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sham auricular acupressure therapy sham auricular acupressure therapy 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. Auricular acupressure therapy auricular acupressure therapy 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)
- Primary Outcome Measures
Name Time Method clinical response rate 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
- Secondary Outcome Measures
Name Time Method change of PSQI scores at the first followup change from baseline PSQI scores at 12 weeks 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).
change of PSQI scores at the end of treatment change from baseline PSQI scores at 8 weeks 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).
change of PSQI scores at the second followup change from baseline PSQI scores at 16 weeks 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).
weekly dose of hypnotics 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) 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.
adverse events through study completion, an average of 20 weeks 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.
change of PSQI scores at the third followup change from baseline PSQI scores at 20 weeks 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).
Trial Locations
- Locations (6)
Guangzhou HEMC (Higher Education Mega Center) Hospital
🇨🇳Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Chinese Medicine
🇨🇳Guangzhou, Guangdong, China
Guangzhou Hospital of Traditional Chinese Medicine
🇨🇳Guangzhou, Guangdong, China
Guangzhou Charity Hospital
🇨🇳Guangzhou, Guangdong, China
Wuyi Hospital of Traditional Chinese Medicine
🇨🇳Jiangsu Sheng, Guangdong, China
Shenzhen Hospital of Traditional Chinese Medicine
🇨🇳Shebu, Guangdong, China