Efficacy and Safety of Valerian Root Extract and Lavender Essential Oil Combination, Over 4 Weeks in Subjects With Sleep Complaints

NCT05194618 | Completed Phase 2

• 1 other identifier: CHUBX 2021/17
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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 sleep quality or duration and it is accompanied by difficulties in initiating sleep at bedtime, frequent or prolonged awakenings, or early-morning awakening with an inability to return to sleep. Lavender oil as well as valerian officinalis are benefiting from a long traditional use in sleep and these products have moderate sedative effects compared to classical hypnotic compounds. This study is proposed to assess the efficacy and the safety of this combination in subjects with slight to moderate sleep complaints.

Conditions

Sleep

Keywords

Sleep; Sleep complaint; valerian; lavender

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index

  The Insomnia Severity Index is a 7-item self-administered questionnaire asking about difficulties sleeping and thoughts and worries about sleep. A 5-point scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: * absence of insomnia (0-7); * sub-threshold insomnia (8-14); * moderate insomnia (15-21); and * severe insomnia (22-28).

  Day28 after inclusion (Day1)

Secondary Outcomes (9)

• Sleep onset latency

  Change from baseline (Day 1) to end of supplementation (Day 28)

• Sleep efficiency

  Change from baseline (Day 1) to end of supplementation (Day 28)

• Wake after sleep onset

  Change from baseline (Day 1) to end of supplementation (Day 28)

• Total sleep time

  Change from baseline (Day 1) to end of supplementation (Day 28)

• Time in bed

  Change from baseline (Day 1) to end of supplementation (Day 28)

Study Arms (2)

Valerian/Lavender arm

EXPERIMENTAL

Participants in this arm will receive actives products : 420 mg per tablet of Valerian root extract and 40 mg per tablet of essential oil of Lavender

Dietary Supplement: Valerian - lavender

Placebo arm

PLACEBO COMPARATOR

Participants in this arm will receive placebo (no active product)

Dietary Supplement: Placebo

Interventions

Valerian - lavender DIETARY_SUPPLEMENT

1 tablet per day, half hour before bedtime, day 1 to day 28

Valerian/Lavender arm

Placebo DIETARY_SUPPLEMENT

1 tablet per day, half hour before bedtime, day 1 to day 28

Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• University of Bordeaux: collaborator

Study Sites (1)

CHU de Bordeaux

Bordeaux, France

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: comparative, randomized, double-blind, placebo-controlled, parallel groups study

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: January 18, 2022
• Study Start: February 2, 2022
• Primary Completion: March 2, 2023
• Study Completion: March 2, 2023
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)