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Sleep DisturbanceNCT05748574

Sleep Well Observation Study

A study testing Sleep Well Sachet in people with Sleep Disturbance, run by A. Vogel AG at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Sleep Disturbance
What is being tested?
Sleep Well Sachet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteGermany
Study dates
14 Mar 2023to 3 Aug 2023
Phase
Interventional
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 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • • 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

Who cannot join

  • • 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).
Show all 16Show fewer
  • 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.
  • Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • daacro GmbH & Co. KG

    Trier, Rhineland-Palatinate, 54296

Other trials in Germany

About this study

Official title: The Sleep Well Observation Study: a Single-arm, Open-label, Prospective Intra-individual Change Controlled, Exploratory Pilot Study

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".

Read the detailed description

This single-center study is a one-armed, open-label, prospective, observational exploratory pilot study and has a duration of 17 days per participant. A total of 50 healthy participants (n=25 female, n=25 male) aged 18-50 years inclusive reported sleep problems at a preliminary stage to the criteria of the German "S3 guideline non-restorative sleep/sleep disorders - insomnia in adults" for the definition of non-organic insomnia according to ICD-10 (F 51.0) are included into the study.

The total study population of N=50 will include two groups: A subgroup of n=40 will not undergo polysomnographic assessment (nonPSG), a group of n=10 will undergo polysomnographic assessment (PSG), in addition to all other assessments. The nonPSG group has a total of 3 study centre visits (V1, V2, V3) and and the PSG group has two further visits prior to V2 and V3 resulting in five study centre visits (V1, V2-1, V2, V3-1, V3). Except for the PSG, all other assessments are identical in the two groups.

All included individuals will take one Sleep Well sachet daily over an intake period of 14 days with an acute dosage at two visits.

Being tested
Sleep Well Sachet
Keywords
sleep, herbal supplement, pilot trial
Medical subject headings
Parasomnias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sleep Well SachetDietary 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

Study groups in NCT05748574
Study groupRoleWhat they receive
Sleep Well Sachet "Treatment"ExperimentalSachet 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.
Receives: Dietary Supplement: Sleep Well Sachet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in perceived sleep quantity/quality

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

    Measured: 2 weeks intervention

  2. Change in perceived sleep quantity/quality

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

    Measured: 1 day intervention

Secondary outcomes (13)

  1. Change in perceived sleep quantity/quality summarized retrospectively

    Method: standardized sleep questionnaire SF-B/R. Comparing pre vs. post intervention assessment on site.

    Measured: 2 weeks

  2. Change in daytime sleepiness

    Pre vs. Post intervention assessment of daytime sleepiness measured with the ESS (Epworth Daytime sleepiness scale) questionnaire

    Measured: 2 weeks

  3. Change in state anxiety

    Pre vs. Post intervention assessment of experienced anxiety symptoms via the STAI-X1 questionnaire

    Measured: 1 day intervention and 2 weeks

  4. Change in negative emotional state

    Pre vs. Post intervention assessment of anxiety depression and stress symptoms measured via the DASS-21 questionnaire

    Measured: 2 weeks

  5. Change in quality of life

    Pre vs. Post intervention assessment of life quality via the WHO-QOL-BREF questionnaire

    Measured: 2 weeks

  6. Change in domain specific cognitive performance

    Pre- vs. Post intervention assessment of domain specific cognitive performance via the COMPASS battery such as attention and vigilance, working memory, spatial memory, memory, executive functions

    Measured: 1 day and 2 weeks

  7. Change in biomarker for chronic stress

    Change in biomarker for chronic stress via the salivary evening cortisol level taken at 8 pm on two days pre-intervention and 2 days post intervention

    Measured: 2 weeks

  8. Change in biomarker for sleep readiness

    Change in biomarker for sleep readiness via the salivary evening melatonin level taken at 8 pm on two days pre intervention and two days post intervention.

    Measured: 2 weeks

  9. Change in biomarker for chronic stress via CAR

    Change in biomarker for chronic stress via CAR (measured immediately at awakening, +30 min and +45 min thereafter) determined as area under the curve (AUC) and increase in biosamples taken on two days pre intervention and two days post intervention.

    Measured: 2 weeks

  10. Change in PSG-recorded sleep quantity/quality

    Pre vs. Post intervention assessment as measured by the polysomnographic "PSG" assessment using a home portable device

    Measured: 1 day intervention and 2 weeks

  11. Tolerability of the investigational product in view of subject

    Tolerability of the product as per the self-declaration of the subject - safety assessment

    Measured: 1 day and 2 weeks

  12. Adverse events

    Frequency and kind of adverse events/medical events during the course of the study - safety assessment

    Measured: 1 day and 2 weeks

  13. Change in physiological sleep quantity/quality

    Measured by actigraphy (wearable). Comparing pre vs. post intervention assessment as Minutes Asleep (minutes spent in deep, rapid-eye-movement (REM), light or asleep stages), Minutes Awake (number of minutes spent in wake or awake stages), Minutes to fall asleep (number of minutes it took to fall asleep), Time in Bed (number of minutes spent in bed (minutes after wakeup + minutes asleep + minutes awake + minutes to fall asleep))

    Measured: 1 day and 2 weeks intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2023
  2. Study start14 Mar 2023
  3. Primary completion3 Jun 2023
  4. Study completion3 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05748574
Sponsor's protocol ID
5'000'749-1
Status last verified
Aug 2024
First submitted
20 Feb 2023
Last updated
6 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sleep Well Sachet in people with Sleep Disturbance, run by A. Vogel AG at 1 site in Germany.

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 8 inclusion and 16 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: finished, as of the sponsor's last update on 6 Aug 2024. 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 Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in perceived sleep quantity/quality (time frame: 2 weeks intervention). 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 NCT05748574.

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 6 Aug 2024.

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Sleep Well Observation Study (NCT05748574) | AzTrials