A randomized, double-blind, placebo-controlled, cross-over pilot study to investigate the efficacy of Rest-ZZZ formula in healthy participants with occasional sleeplessness.

Authors:
Moulin M; Lewis ED; Crowley DC; Langston J; Evans M.

Journal:
Sleep Biol Rhythms

Publication Year: 2022

DOI:
10.1007/s41105-022-00416-2

PMCID:
PMC10900002

PMID:
38468905

Journal Information

Journal Title: Sleep Biol Rhythms

Detailed journal information not available.

Publication Details

Subject Category: Clinical Neurology

Available in Europe PMC: Yes

Available in PMC: Yes

PDF Available: No

Transparency Score
4/6
66.7% Transparent
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Evidence found in paper:

"Declarations Conflict of interestJ.L. is the Chief Research Officer at LifeSeasons, Inc. M.M., E.L., M.E., D.C., and A.S. have no financial interests in or conflict with the subject matter or materials discussed. Ethics approvalThis study was approved by the Natural Health Product Directorate (NHPD), Health Canada, Ottawa, Ontario on August 26th, 2019. Research ethics board approval was granted on August 13th, 2019 by the Institutional Review Board IRB Services, Aurora, Ontario. The study was conducted in compliance with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) and in accordance with the Declaration of Helsinki guidelines and its subsequent amendments. This study was registered with ClinicalTrials.gov (NCT04093271). Consent to participateInformed consent was obtained from all individual participants included in this study. Conflict of interest J.L. is the Chief Research Officer at LifeSeasons, Inc. M.M., E.L., M.E., D.C., and A.S. have no financial interests in or conflict with the subject matter or materials discussed."

Evidence found in paper:

"Funding This study was funded by LifeSeasons, Inc."

Evidence found in paper:

"Declarations: Conflict of interestJ.L. is the Chief Research Officer at LifeSeasons, Inc. M.M., E.L., M.E., D.C., and A.S. have no financial interests in or conflict with the subject matter or materials discussed.: Ethics approvalThis study was approved by the Natural Health Product Directorate (NHPD), Health Canada, Ottawa, Ontario on August 26th, 2019. Research ethics board approval was granted on August 13th, 2019 by the Institutional Review Board IRB Services, Aurora, Ontario. The study was conducted in compliance with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) and in accordance with the Declaration of Helsinki guidelines and its subsequent amendments. This study was registered with ClinicalTrials.gov (NCT04093271).: Consent to participateInformed consent was obtained from all individual participants included in this study. Ethics approval: This study was approved by the Natural Health Product Directorate (NHPD), Health Canada, Ottawa, Ontario on August 26th, 2019. Research ethics board approval was granted on August 13th, 2019 by the Institutional Review Board IRB Services, Aurora, Ontario. The study was conducted in compliance with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) and in accordance with the Declaration of Helsinki guidelines and its subsequent amendments. This study was registered with ClinicalTrials.gov (NCT04093271)."

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Paper is freely available to read
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Last Updated: Aug 05, 2025