Clinical trial NCT05748574: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Keywords: sleep
herbal supplement
pilot trial
Lead sponsor: A. Vogel AG
Sponsor class: INDUSTRY
Collaborators: name: Daacro GmbH & Co. KG
name: Biochemical Laboratory of the Department of Psychobiology, University of Trier
name: SYNLAB GmbH
First posted: 2023-02-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in perceived sleep quantity/quality
timeFrame: 2 weeks intervention
measure: Change in perceived sleep quantity/quality
timeFrame: 1 day intervention
Secondary outcomes:
measure: Change in perceived sleep quantity/quality summarized retrospectively
timeFrame: 2 weeks
measure: Change in daytime sleepiness
timeFrame: 2 weeks
measure: Change in state anxiety
timeFrame: 1 day intervention and 2 weeks
measure: Change in negative emotional state
timeFrame: 2 weeks
measure: Change in quality of life
timeFrame: 2 weeks
measure: Change in domain specific cognitive performance
timeFrame: 1 day and 2 weeks
measure: Change in biomarker for chronic stress
timeFrame: 2 weeks
measure: Change in biomarker for sleep readiness
timeFrame: 2 weeks
measure: Change in biomarker for chronic stress via CAR
timeFrame: 2 weeks
measure: Change in PSG-recorded sleep quantity/quality
timeFrame: 1 day intervention and 2 weeks
measure: Tolerability of the investigational product in view of subject
timeFrame: 1 day and 2 weeks
measure: Adverse events
timeFrame: 1 day and 2 weeks
measure: Change in physiological sleep quantity/quality
timeFrame: 1 day and 2 weeks intervention
Other outcomes:
Locations:
city: Trier
country: Germany
facility: daacro GmbH & Co. KG
state: Rheinland-Pfalz
Study officials:
affiliation: daacro GmbH & Co. KG, Science Park Trier, Max-Planck-Str. 22, 54296 Trier/Germany
name: Juliane Hellhammer, Dr
role: PRINCIPAL_INVESTIGATOR
References: