Evaluation of a Combination of Plants in Anxiety-related Sleep Disorders: Randomized Trial Versus Placebo

NCT04812418 | Completed

• 1 other identifier: Pil-Clin-Noct-020
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this double-blind randomized clinical trial is to compare the effects of a dietary supplement based on eschscholtzia and valerian extracts to a placebo after 28 days of supplementation, in subjects suffering from sleep troubles associated with anxiety.

Conditions

Sleep Troubles Associated With Anxiety

Outcome Measures

Primary Outcomes (1)

• Sleep disorder severity

  Change from baseline of Insomnia Severity Index (ISI) score

  Baseline and D28 (end of supplementation)

Secondary Outcomes (12)

• Sleep disorder severity over time

  Baseline and D49 (end of follow-up)

• Investigator assessment of sleep disorder symptoms severity

  Baseline and D28 (end of supplementation)

• Investigator assessment of sleep disorder symptoms improvement

  Baseline and D28 (end of supplementation)

• Patient assessment of sleep disorder symptoms improvement after intervention

  Baseline and D28 (end of supplementation)

• Anxiety status

  Baseline and D28 (end of supplementation)

Study Arms (2)

Group (A)

EXPERIMENTAL

120 mg of eschscholtzia extract and 50 mg of valerian extract by tablet, without support 28 days

Dietary Supplement: Noctesia

Group (B)

PLACEBO COMPARATOR

Placebo 28 days

Dietary Supplement: Placebo

Interventions

Noctesia DIETARY_SUPPLEMENT

3 tablets every day at bedtime with a large glass of water

Group (A)

Placebo DIETARY_SUPPLEMENT

3 tablets every day at bedtime with a large glass of water

Group (B)

Eligibility Criteria

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

You may qualify if:

• Woman or man, aged of 18 to 65 years;
• In good general health as evidenced by medical history and physical examination;
• Having at least 3 episodes of sleep disorders per week including one or more of the following:
• difficulty falling asleep or
• difficulty staying asleep or
• poor quality sleep
• Waking up earlier than desired
• The insufficient sleep duration and quality is coupled with a feeling of general fatigue;
• Sleep disorder last for more than 1 month;
• Presenting moderate to severe sleep disorder in the past month (ISI ≥ 15);
• With anxiety resulting in a HAM-A score \> 8 and \< 25;
• For women of childbearing age (women of childbearing potential, pre-menopausal or having postmenopausal amenorrhea of less than 12 months, and women who have not undergone surgical sterilization):
• Negative blood pregnancy test
• Acceptance to use an effective method of contraception, established for at least 1 month, and throughout the duration of the study;
• Fluent French speaking;

You may not qualify if:

• A score \> 10 on the ESS scale (that would correspond to serious hypersomnia);
• Sleep disorders secondary to another health problem (sleep apnea syndrome, narcolepsy-cataplexy, idiopathic hypersomnia, restless legs syndrome, chronic pain syndrome, ...) or an environmental factor (noise, light ...) or socio-professional (shift work, young child at home, people who are often jet lagged,… );
• Subjects presenting severe gastro-intestinal, hepatic, respiratory, kidney or cardiovascular disorder or severe infection (e.g. HIV, hepatitis, …);
• Acute or chronic somatic pathologies which can interfere with sleep: kidney cancer, etc.;
• Subjects with pre-menstrual syndrome or myasthenia gravis;
• Subjects who drink more than 2 glasses of alcohol per day (\> 20g of alcohol per day) or with exaggerated consumption of theine (≥ 1l per day) and caffeine-rich (≥ 800ml per day) beverages and energy drink (≥ 330ml per day);
• Smoker;
• Subject consuming drugs and/or with historical drug addiction;
• Under psychotropic treatment within the last month before screening (neuroleptic, anxiolytic, antidepressant, hypnotic, sedative, …) or under current medication treatment which may alter the waking state (for example: cortisone, dopamine, amphetamine, antihistamines, beta-blockers, certain cough syrups, .…);
• Volunteer with suicidal risk according to the investigator;
• Under phytotherapy treatment or food supplement for sleep disorders within the last month before screening;
• Volunteer presenting current infection and/or fever;
• Volunteer with medical history of stroke or head trauma;
• Pregnant or lactating woman;
• Known allergy or intolerance to one product component (valerian, eschscholtzia or excipients);

Sponsors & Collaborators

• PiLeJe: lead
• Université Catholique de Louvain: collaborator

Study Sites (1)

Centre d'Investigation Clinique en Nutrition

Louvain-la-Neuve, B-1348, Belgium

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: March 23, 2021
• Study Start: March 29, 2021
• Primary Completion: May 17, 2023
• Study Completion: June 9, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)