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Sleep Well Observation Study

NCT05748574 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-08-06

No results posted yet for this study

Summary

Insomnia is characterized by the recurring difficulty to fall or remain asleep despite motivation and means to do so. People with insomnia also experience excessive daytime sleepiness and other cognitive impairments while they are awake. Facing the situation mentioned and realizing that especially early preventive measures are needed to fight the increasing costs for treatment of sleep related diseases, effective nutrients might be a good and safe option to improve sleep quality.This single-arm, open-label, prospective, observational exploratory pilot study aims at collecting first data on efficacy and safety of "Sleep Well".

Conditions

  • Sleep Disturbance

Interventions

DIETARY_SUPPLEMENT

Sleep Well Sachet

Individuals will take 1 Sleep Well sachet daily over 2 weeks Exception: Two sachets are taken on days 4 and 17 upon acute assessment

Sponsors & Collaborators

  • Daacro GmbH & Co. KG

    collaborator UNKNOWN

  • Biochemical Laboratory of the Department of Psychobiology, University of Trier

    collaborator UNKNOWN

  • SYNLAB GmbH

    collaborator UNKNOWN

  • A. Vogel AG

    lead INDUSTRY

Principal Investigators

  • Juliane Hellhammer, Dr · daacro GmbH & Co. KG, Science Park Trier, Max-Planck-Str. 22, 54296 Trier/Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-14
Primary Completion
2023-06-03
Completion
2023-08-03

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05748574 on ClinicalTrials.gov