InsomniaNCT05978271
Appraising Clinical Trial Experiences of Patients With Insomnia
An observational study of Insomnia, run by Power Life Sciences Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2024to Aug 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with insomnia who are actively considering involvement in an observational clinical research, but have not yet completed enrollment and registration.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Power Life Sciences
San Francisco, California, 94107
Michael B Gill, 415-900-4227, https://www.withpower.com/contact-us@withpower.com
About this study
Official title: An Observational Study Investigating the Experience of Patients Undergoing Active Insomnia Clinical Trials
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.
- Conditions
- Insomnia
- Keywords
- Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients who decide to enroll in an insomnia clinical research.
Measured: 3 months
Number of insomnia patients who remain in clinical study until completion.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study startAug 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Power Life Sciences Inc.The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MichaelB B Gill, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978271
- Sponsor's protocol ID
- 81875001
- Status last verified
- Jul 2023
- First submitted
- 28 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 35797047Liang 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.
PubMed 32744037Anand 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.
PubMed 28391425
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Investigating the Experience of Patients Undergoing Active Insomnia Clinical Trials
- ClinicalTrials.gov ID
- NCT05978271
- Acronym / sponsor ID
- 81875001
- Conditions
- Insomnia
- Keywords
- Insomnia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 7 Aug 2023 (actual)
- 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.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with insomnia who are actively considering involvement in an observational clinical research, but have not yet completed enrollment and registration.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Background: PubMed 35797047Yin 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.
- Background: PubMed 32744037Liang 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.
- Background: PubMed 28391425Anand 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.
- Individual participant dataSharing planned: Undecided
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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.
MichaelB B Gill study director
Power Life Sciences Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia, run by Power Life Sciences Inc. at 1 site in United States.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael B Gill (415-900-4227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients who decide to enroll in an insomnia clinical research. (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT05978271, which also lists 3 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 7 Aug 2023.