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NCT05978271 Clinical Trial

Appraising Clinical Trial Experiences of Patients With Insomnia

Insomnia Clinical Trial

Official title:
An Observational Study Investigating the Experience of Patients Undergoing Active Insomnia Clinical Trials

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05978271
Other study ID # 81875001
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 2024
Est. completion date August 2026

Study information
Verified date July 2023
Source Power Life Sciences Inc.
Contact Michael B Gill
Phone 415-900-4227
Email bask@withpower.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 500
Est. completion date August 2026
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Insomnia
  • Sleep Initiation and Maintenance Disorders

Locations
Country Name City State
United States Power Life Sciences San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Power Life Sciences Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of patients who decide to enroll in an insomnia clinical research. 3 months
Primary Number of insomnia patients who remain in clinical study until completion. 12 months
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