Sleep Well Observation Study

NCT05748574 | Completed

• 1 other identifier: 5'000'749-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

sleep; herbal supplement; pilot trial

Outcome Measures

Primary Outcomes (2)

• Change in perceived sleep quantity/quality

  Measured as per daily electronic sleep diary entries at home. Comparing pre vs. post intervention assessment.

  2 weeks intervention

• Change in perceived sleep quantity/quality

  Measured as per daily electronic sleep diary entries at home. Comparing pre vs. post intervention assessment.

  1 day intervention

Secondary Outcomes (13)

• Change in perceived sleep quantity/quality summarized retrospectively

  2 weeks

• Change in daytime sleepiness

  2 weeks

• Change in state anxiety

  1 day intervention and 2 weeks

• Change in negative emotional state

  2 weeks

• Change in quality of life

  2 weeks

Study Arms (1)

Sleep Well Sachet "Treatment"

EXPERIMENTAL

Sachet of Sleep Well direct granulate (2.0 g) 1 sachet contains: 190 mg standardized dry extract of Melissa officinalis leaf , 75 mg dried pressed juice of fresh Lactuca sativa herb, 0.41 g Magnesiumdicitrate, 0.12 g L-Tryptophan, excipients and natural flavors.

Dietary Supplement: Sleep Well Sachet

Interventions

Sleep Well Sachet DIETARY_SUPPLEMENT

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

Sleep Well Sachet "Treatment"

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntary, written, informed consent to participate in the study.
• Male or female aged between 18-50 years (inclusive).
• Self reported sleep problems precursing the criteria of the German "S3 guideline non-restorative sleep/sleep disorders - insomnia in adults".
• Habitual bedtime between 9 pm and midnight.
• Agreement to avoid foods such as pitted fruit, bananas and chocolate 24 hours before saliva sample collection.
• Willing to download wearable app.
• Easy access to internet for daily e-diary.
• Cooling capacities available for storage of saliva samples

You may not qualify if:

• Body mass index (BMI) \<18.0 or \>30.0 kg/m2.
• Women who are currently pregnant or breastfeeding.
• Any known history of a disorder affecting sleep quality, such as narcolepsy, obstructive sleep apnea (OSA), restless leg syndrome (RLS), periodic limb movement syndrome (PLMS) or any organic caused sleep disorders e.g. benign prostatic hyperplasia (BPH), renal insufficiency, hepatopathy, urinary tract infections, irritated bladder, or any psychiatric disorder, e.g. depression, anxiety.
• Have a significant acute or chronic coexisting illness or any condition which contraindicates entry to the study in the opinion of the Investigator (e.g. migraines, active infections).
• Previous (last 4 weeks prior to screening) or current intake of drugs that could influence sleep patterns including hormone therapy, health products and oriental herbs.
• Binge drinking (males \>140 g/week, females \>70 g/week), heavy smoking (\>10 cigarettes/day), high caffeine intake (\>10 glasses/day).
• Self-declared illicit drug use (including cannabis and cocaine) for 3 months prior to screening and during the intervention period.
• Have a high blood pressure (systolic over 159 mmHg or diastolic over 99 mmHg).
• Have learning and/or behavioural difficulties such as dyslexia or attention deficit hyperactivity disorder (ADHD).
• Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness).
• History or planned travel to a different time zone within 1 month of the first visit or/and during the study participation.
• Not fluent in German.
• Have relevant food allergies/intolerances/sensitivities to any substance in the study product.
• Have oral disease.
• Participation in another study with any investigational product within 30 days of screening and during the intervention period.

Sponsors & Collaborators

• A. Vogel AG: lead
• Daacro GmbH & Co. KG: collaborator
• Biochemical Laboratory of the Department of Psychobiology, University of Trier: collaborator
• SYNLAB GmbH: collaborator

Study Sites (1)

daacro GmbH & Co. KG

Trier, Rhineland-Palatinate, 54296, Germany

Location

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Juliane Hellhammer, Dr

  daacro GmbH & Co. KG, Science Park Trier, Max-Planck-Str. 22, 54296 Trier/Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: February 28, 2023
• Study Start: March 14, 2023
• Primary Completion: June 3, 2023
• Study Completion: August 3, 2023
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)