Appraising Clinical Trial Experiences of Patients With Insomnia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Insomnia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Observational Study Investigating the Experience of Patients Undergoing Active Insomnia Clinical Trials
Overview
Medical research participation percentages haven't always been fully representative of a given demographic. The goal is to find out which aspects of a clinical trial may make it more difficult for patients to take part or see it through. The data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future insomnia patients during clinical study.
Primary outcome measures
- Rate of patients who decide to enroll in an insomnia clinical research. [Time frame: 3 months]
- Number of insomnia patients who remain in clinical study until completion. [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.
- Participant has a diagnosis of insomnia.
- Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.
Exclusion criteria
- Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.
- Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results.
- Pregnant or lactating woman
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-crossover
Study locations
United States · 1 center
- Power Life Sciences — San Francisco
Publications
- Yin X, Li W, Liang T, Lu B, Yue H, Li S, Zhong VW, Zhang W, Li X, Zhou S, Mi Y, Wu H, Xu S. Effect of Electroacupuncture on Insomnia in Patients With Depression: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2220563. doi: 10.1001/jamanetworkopen.2022.20563. PMID 35797047
- Liang X, Wang Q, Jiang Z, Li Z, Zhang M, Yang P, Wang X, Wang Y, Qin Y, Li T, Zhang T, Wang Y, Sun J, Li Y, Luo H, Li L. Clinical research linking Traditional Chinese Medicine constitution types with diseases: a literature review of 1639 observational studies. J Tradit Chin Med. 2020 Aug;40(4):690-702. doi: 10.19852/j.cnki.jtcm.2020.04.019. PMID 32744037
- Anand S, Tong H, Besag FMC, Chan EW, Cortese S, Wong ICK. Safety, Tolerability and Efficacy of Drugs for Treating Behavioural Insomnia in Children with Attention-Deficit/Hyperactivity Disorder: A Systematic Review with Methodological Quality Assessment. Paediatr Drugs. 2017 Jun;19(3):235-250. doi: 10.1007/s40272-017-0224-6. PMID 28391425
Identifiers
NCT: NCT05978271 · 81875001