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Sleep Well Observation Study

Primary Purpose

Sleep Disturbance

Status
Not yet recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Sleep Well Sachet
Sponsored by
A. Vogel AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disturbance focused on measuring sleep, herbal supplement, pilot trial

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: • 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 Exclusion Criteria: • 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. Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study.

Sites / Locations

  • daacro GmbH & Co. KG

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sleep Well Sachet "Treatment"

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in perceived sleep quantity/quality
Measured as per daily electronic sleep diary entries at home. Comparing pre vs. post intervention assessment.
Change in perceived sleep quantity/quality
Measured as per daily electronic sleep diary entries at home. Comparing pre vs. post intervention assessment.

Secondary Outcome Measures

Change in perceived sleep quantity/quality summarized retrospectively
Method: standardized sleep questionnaire SF-B/R. Comparing pre vs. post intervention assessment on site.
Change in daytime sleepiness
Pre vs. Post intervention assessment of daytime sleepiness measured with the ESS (Epworth Daytime sleepiness scale) questionnaire
Change in state anxiety
Pre vs. Post intervention assessment of experienced anxiety symptoms via the STAI-X1 questionnaire
Change in negative emotional state
Pre vs. Post intervention assessment of anxiety depression and stress symptoms measured via the DASS-21 questionnaire
Change in quality of life
Pre vs. Post intervention assessment of life quality via the WHO-QOL-BREF questionnaire
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
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
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.
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.
Change in PSG-recorded sleep quantity/quality
Pre vs. Post intervention assessment as measured by the polysomnographic "PSG" assessment using a home portable device
Tolerability of the investigational product in view of subject
Tolerability of the product as per the self-declaration of the subject - safety assessment
Adverse events
Frequency and kind of adverse events/medical events during the course of the study - safety assessment
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))

Full Information

First Posted
February 20, 2023
Last Updated
March 6, 2023
Sponsor
A. Vogel AG
Collaborators
Daacro GmbH & Co. KG, Biochemical Laboratory of the Department of Psychobiology, University of Trier, SYNLAB GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05748574
Brief Title
Sleep Well Observation Study
Official Title
The Sleep Well Observation Study: a Single-arm, Open-label, Prospective Intra-individual Change Controlled, Exploratory Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 14, 2023 (Anticipated)
Primary Completion Date
June 3, 2023 (Anticipated)
Study Completion Date
August 3, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
A. Vogel AG
Collaborators
Daacro GmbH & Co. KG, Biochemical Laboratory of the Department of Psychobiology, University of Trier, SYNLAB GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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".
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance
Keywords
sleep, herbal supplement, pilot trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleep Well Sachet "Treatment"
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Sleep Well Sachet
Intervention Description
Individuals will take 1 Sleep Well sachet daily over 2 weeks Exception: Two sachets are taken on days 4 and 17 upon acute assessment
Primary Outcome Measure Information:
Title
Change in perceived sleep quantity/quality
Description
Measured as per daily electronic sleep diary entries at home. Comparing pre vs. post intervention assessment.
Time Frame
2 weeks intervention
Title
Change in perceived sleep quantity/quality
Description
Measured as per daily electronic sleep diary entries at home. Comparing pre vs. post intervention assessment.
Time Frame
1 day intervention
Secondary Outcome Measure Information:
Title
Change in perceived sleep quantity/quality summarized retrospectively
Description
Method: standardized sleep questionnaire SF-B/R. Comparing pre vs. post intervention assessment on site.
Time Frame
2 weeks
Title
Change in daytime sleepiness
Description
Pre vs. Post intervention assessment of daytime sleepiness measured with the ESS (Epworth Daytime sleepiness scale) questionnaire
Time Frame
2 weeks
Title
Change in state anxiety
Description
Pre vs. Post intervention assessment of experienced anxiety symptoms via the STAI-X1 questionnaire
Time Frame
1 day intervention and 2 weeks
Title
Change in negative emotional state
Description
Pre vs. Post intervention assessment of anxiety depression and stress symptoms measured via the DASS-21 questionnaire
Time Frame
2 weeks
Title
Change in quality of life
Description
Pre vs. Post intervention assessment of life quality via the WHO-QOL-BREF questionnaire
Time Frame
2 weeks
Title
Change in domain specific cognitive performance
Description
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
Time Frame
1 day and 2 weeks
Title
Change in biomarker for chronic stress
Description
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
Time Frame
2 weeks
Title
Change in biomarker for sleep readiness
Description
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.
Time Frame
2 weeks
Title
Change in biomarker for chronic stress via CAR
Description
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.
Time Frame
2 weeks
Title
Change in PSG-recorded sleep quantity/quality
Description
Pre vs. Post intervention assessment as measured by the polysomnographic "PSG" assessment using a home portable device
Time Frame
1 day intervention and 2 weeks
Title
Tolerability of the investigational product in view of subject
Description
Tolerability of the product as per the self-declaration of the subject - safety assessment
Time Frame
1 day and 2 weeks
Title
Adverse events
Description
Frequency and kind of adverse events/medical events during the course of the study - safety assessment
Time Frame
1 day and 2 weeks
Title
Change in physiological sleep quantity/quality
Description
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))
Time Frame
1 day and 2 weeks intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • 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 Exclusion Criteria: • 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. Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ramon Weishaupt, Dr
Phone
0714546124
Email
r.weishaupt@avogel.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Roland Schoop, Dr
Phone
0714546205
Email
r.schoop@avogel.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliane Hellhammer, Dr
Organizational Affiliation
daacro GmbH & Co. KG, Science Park Trier, Max-Planck-Str. 22, 54296 Trier/Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
daacro GmbH & Co. KG
City
Trier
State/Province
Rheinland-Pfalz
ZIP/Postal Code
54296
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliane Hellhammer, Dr
Phone
+49 (0) 651 9120 494
Email
hellhammer@daacro.de

12. IPD Sharing Statement

Plan to Share IPD
No

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Sleep Well Observation Study

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