NCT05748574

Sleep Well Observation Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: A. Vogel AG · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sleep Disturbance

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-03-14
• Primary completion: 2023-06-03
• Completion: 2023-08-03
• First posted: 2023-02-28
• Last updated: 2024-08-06

Locations

1 site across 1 country: Germany