Acupuncture for insomnia with short sleep duration: protocol for a randomised controlled trial
Open Access
- 4 March 2020
- Vol. 10 (3), e033731
- https://doi.org/10.1136/bmjopen-2019-033731
Abstract
Introduction Insomnia with short sleep duration has a more serious negative impact on patient health. The existing literature suggests that medication therapy is more effective for this phenotype of insomnia compared with cognitive–behavioural therapy. However, the potential side effects of hypnotic medications hinder their clinical application. Acupuncture has been widely used in the treatment of insomnia, but it remains unclear whether it has therapeutic efficacy for insomnia with short sleep duration. The purpose of this trial is to evaluate the efficacy and safety of acupuncture for insomnia with short sleep duration. Methods and analysis This study is designed as a randomised, single-centre, single-blinded, placebo acupuncture controlled trial involving 152 participants. Eligible patients will be divided into two groups according to the objective total sleep time: insomnia with normal sleep duration group and insomnia with short sleep duration group. Then, patients in each group will be randomly assigned to two subgroups, the treatment group (acupuncture) and the control group (placebo acupuncture), in a 1:1 ratio with 38 subjects in each subgroup. The primary outcome is the Pittsburgh Sleep Quality Index and the Insomnia Severity Index. Secondary outcomes are actigraphy, the Beck Anxiety Inventory, the Beck Depression Inventory and the Fatigue Severity Scale. All adverse effects will be assessed by the Treatment Emergent Symptom Scale. Outcomes will be evaluated at baseline, post treatment, as well as at 1-week and 1-month follow-up. Ethics and dissemination This protocol has been approved by the ethics committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine (no. 2019-17). Written informed consent will be obtained from all participants. The results will be disseminated through peer-reviewed journals for publications. Trial registration number ChiCTR1900023473; Pre-results.Funding Information
- the Shanghai Science and Technology Commission (18401971000)
- The National Natural Science Funds of China (81503631)
- The Interdisciplinary Project of “Clinical Immunology of Traditional Chinese Medicine” in Shanghai (30304113598)
- the Shanghai Municipal Commission of Health and Family Planning (ZYKC201703006)
- The Construction of Chinese Medicine Heritage Innovation Platform (ZY (2018-2020)-CCCX-2004-03)
This publication has 78 references indexed in Scilit:
- Insomnia With Short Sleep Duration: Nosologic, Diagnostic, and Treatment ImplicationsSleep Medicine Clinics, 2013
- Effects of Aroma Massage on Home Blood Pressure, Ambulatory Blood Pressure, and Sleep Quality in Middle-Aged Women with HypertensionEvidence-Based Complementary and Alternative Medicine, 2013
- Validity of the “Streitberger” Needle in a Chinese Population with Acupuncture: A Randomized, Single-Blinded, and Crossover Pilot StudyEvidence-Based Complementary and Alternative Medicine, 2013
- Electroacupuncture for Residual Insomnia Associated with Major Depressive Disorder: A Randomized Controlled TrialSleep, 2011
- The Efficacy and Safety of Drug Treatments for Chronic Insomnia in Adults: A Meta-analysis of RCTsJournal of General Internal Medicine, 2007
- Interventions and Physician Characteristics in a Randomized Multicenter Trial of Acupuncture in Patients with Low-Back PainThe Journal of Alternative and Complementary Medicine, 2006
- Complementary and alternative medicine whole systems research: Beyond identification of inadequacies of the RCTComplementary Therapies in Medicine, 2005
- Characteristic and incidental (placebo) effects in complex interventions such as acupunctureBMJ, 2005
- A Pilot Study of Inexpensive Sleep-Assessment DevicesBehavioral Sleep Medicine, 2004
- Validation of the Insomnia Severity Index as an outcome measure for insomnia researchSleep Medicine, 2001