Status:
COMPLETED
Efficacy and Safety of Valerian Root Extract and Lavender Essential Oil Combination, Over 4 Weeks in Subjects With Sleep Complaints
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
University of Bordeaux
Conditions:
Sleep
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Several epidemiologic studies have clearly shown that sleep complaints are very common in the general population. It involves a predominant complaint of a nonrestorative sleep or dissatisfaction with ...
Detailed Description
Several epidemiologic studies have clearly shown that sleep complaints are very common in the general population. It involves a predominant complaint of a nonrestorative sleep or dissatisfaction with ...
Eligibility Criteria
Inclusion
- Adult subjects (≥ 18 years old) with sleep complaints:
- with a frequency of 1 or 2 times per week, OR
- with a frequency ≥ 3 times per week and duration \< 3 months,
- Sleep complaints are defined as:
- Difficulty initiating sleep, or
- Difficulty maintaining sleep, or
- Early-morning awakening with inability to return to sleep. and
- Causing distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning.
- Insomnia Severity Index (ISI) score comprised between 11 and 21 (slight to moderate sleep complaints)
- BMI inferior to 30 (included)
- Connected to internet and having a smartphone
- Affiliated person or beneficiary of a social security scheme
- Free, informed and written consent signed
Exclusion
- Severe sleep complaints (ISI \> 21) OR insomnia with clinical significance consequences as defined by DSM 5
- Subject with other organic sleep disorders diagnosed (i.e. sleep apnea, Restless Legs Syndrome)
- Subject at high risk of suspicion of Obstructive Sleep Apnea Syndrome (OSAS) on the STOP-BANG questionnaire (Snoring, Tiredness, Observed apnea, blood Pressure, Body mass index, Age, Neck circumference and Gender), or a suspicion of Restless Legs Syndrome (RLS) on the RLS screening questionnaire,
- Subject with a significant medical history in the previous year or still in progress (example: Cancer),
- Subject with acute psychiatric disorder (mood disorders, severe anxiety disorders, psychosis, addiction interfering with nocturnal sleep). Subject with a history of mood or anxiety disorder currently stabilized could be included.
- Having initiated a psychotropic treatment for anxiety or mood disorders in the last 2 months or whose treatment dose has been modified for less than 2 months (antidepressant, anxiolytic and antihistamine treatments will be allowed if they are prescribed for a stabilized mood and/or anxiety disorder)
- Having organic disorders inducing sleep complaints (i.e. Covid \< 6 months)
- Currently treated for insomnia disorders with a pharmaceutical treatment (hypnotic treatments, anxiolytic, antidepressants).
- Taking food supplements aimed at improving sleep quality in the previous month,
- Taking food supplements in the previous month containing valerian root extract or lavender oil
- Taking any pharmaceutical treatment suspected to induce sleep complaints
- Shift workers and social jet lag
- Having undertaken trans-meridian travel (± 3H) in the previous month and/or refusing not to undertake trans-meridian travel (± 3H) )
- Known drug abuse
- Alcohol consumption more than 10 standard drinks per week
- Caffeine consumption more than 5 standard cups/drinks per day
- Participation in a clinical trial in the previous 3 months that may interfere with the evaluation of the primary endpoint (sleep complaints) or exclusion period still on going
- Eating disorders: anorexia and bulimia or unstable dietary pattern;
- Any food allergy documented or suspected to one of the components of the study products;
- Pregnancy or breast-feeding woman (contraceptive mandatory)
- Subject under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision;
Key Trial Info
Start Date :
February 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2023
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT05194618
Start Date
February 2 2022
End Date
March 2 2023
Last Update
March 14 2023
Active Locations (1)
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1
CHU de Bordeaux
Bordeaux, France