Sleep Troubles Associated With AnxietyNCT04812418
Evaluation of a Combination of Plants in Anxiety-related Sleep Disorders: Randomized Trial Versus Placebo
A study testing Noctesia in people with Sleep Troubles Associated With Anxiety, run by PiLeJe at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep Troubles Associated With Anxiety
- What is being tested?
- Noctesia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Mar 2021to 9 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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;
- Provision of signed and dated informed consent form;
- Stated willingness to comply with all study procedures and availability for the duration of the study.
Who cannot join
- 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,… );
- Severe psychiatric disorder or disease within 6 months before inclusion (depression, bipolar disorder, severe anxiety, psychosis, schizophrenic disorders, dementia,…) or a severe neurologic trouble (Alzheimer's, autism, Parkinson's disease, …);
- 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;
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- 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);
- Subjects having participated to another clinical trial (with an investigational product) one month before the inclusion;
- Subjects that present alterations of their cognitive functions that will interfere with the comprehension of the study and procedures and/or with the completion of questionnaires;
- Vulnerable patient (deprived of liberty by judicial or administrative decision, under guardianship, curatorship or safeguard of justice, …);
- Pharmacological resistance to common hypnotic/sedative drugs;
- Allergy/intolerance to the actimeter straps;
- Recent (< 1 month before the inclusion) change in lifestyle (food, body weight > 5kg, sport).
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Centre d'Investigation Clinique en Nutrition
Louvain-la-Neuve, B-1348
About this study
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
- Being tested
- Noctesia, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NoctesiaDietary supplement
3 tablets every day at bedtime with a large glass of water
PlaceboDietary supplement
3 tablets every day at bedtime with a large glass of water
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Experimental | 120 mg of eschscholtzia extract and 50 mg of valerian extract by tablet, without support 28 days Receives: Dietary Supplement: Noctesia |
| Group (B) | Placebo comparator | Placebo 28 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep disorder severity
Change from baseline of Insomnia Severity Index (ISI) score
Measured: Baseline and D28 (end of supplementation)
Secondary outcomes (12)
Sleep disorder severity over time
Change from baseline of Insomnia Severity Index (ISI) score
Measured: Baseline and D49 (end of follow-up)
Investigator assessment of sleep disorder symptoms severity
Change from baseline of Clinical Global Impression Severity (CGI-S) score
Measured: Baseline and D28 (end of supplementation)
Investigator assessment of sleep disorder symptoms improvement
Change from baseline of Clinical Global Impression Improvement (CGI-I) score
Measured: Baseline and D28 (end of supplementation)
Patient assessment of sleep disorder symptoms improvement after intervention
Change from baseline of Patient Global Impression Improvement (PGI-I) score
Measured: Baseline and D28 (end of supplementation)
Anxiety status
Change from baseline of Hamilton anxiety rating scale (HAM-A) score
Measured: Baseline and D28 (end of supplementation)
Anxiety status over time
Change from baseline of Hamilton anxiety rating scale (HAM-A) score
Measured: Baseline and D49 (end of follow-up)
Short-form 36 questionnaire (SF36)
Change from baseline of SF36 scores
Measured: Baseline and D28 (end of supplementation)
Actimeters
Change from baseline of the mean values obtained from actimeters recording during the 7 days
Measured: Baseline, D7, D14, D21 and D28 (end of supplementation)
Electronic sleep diaries
Change from baseline of the mean values obtained from electronic sleep diaries during the 7 days
Measured: Baseline, D7, D14, D21 and D28 (end of supplementation)
Evolution of sleep troubles
Change from baseline of sleep troubles regarding changes in medical prescriptions, reason of changes and number of intercurrent medical visits for sleep disorders
Measured: Baseline, D28 (end of supplementation) and D49 (end of follow-up)
Addiction
Change from baseline of Addiction questionnaire scores
Measured: Baseline and D49 (end of follow-up)
Adverse events
Incidence of adverse events
Measured: Baseline D7, D14, D21, D28 (end of supplementation) and D49 (end of follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start29 Mar 2021
- Primary completion17 May 2023
- Study completion9 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Troubles Associated With AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- PiLeJe
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Université Catholique de Louvain
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812418
- Sponsor's protocol ID
- Pil-Clin-Noct-020
- Status last verified
- Nov 2023
- First submitted
- 15 Jan 2021
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Combination of Plants in Anxiety-related Sleep Disorders: Randomized Trial Versus Placebo
- ClinicalTrials.gov ID
- NCT04812418
- Acronym / sponsor ID
- Pil-Clin-Noct-020
- Conditions
- Sleep Troubles Associated With Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- PiLeJeIndustry (pharma, biotech, devices)
- Collaborators
- Université Catholique de Louvain
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 17 May 2023 (actual)
- Study completion
- 9 Jun 2023 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Experimental | Dietary Supplement: Noctesia120 mg of eschscholtzia extract and 50 mg of valerian extract by tablet, without support 28 days |
| Group (B) | Placebo comparator | Dietary Supplement: PlaceboPlacebo 28 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- The insufficient sleep duration and quality is coupled with a feeling of general fatigue;
- Sleep disorder last for more than 1 month;
Key exclusion criteria (22 listed)
- 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,… );
- Severe psychiatric disorder or disease within 6 months before inclusion (depression, bipolar disorder, severe anxiety, psychosis, schizophrenic disorders, dementia,…) or a severe neurologic trouble (Alzheimer's, autism, Parkinson's disease, …);
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noctesia3 tablets every day at bedtime with a large glass of water | Dietary supplement | Group (A) |
| Placebo3 tablets every day at bedtime with a large glass of water | Dietary supplement | Group (B) |
Primary outcome
Sleep disorder severity
Time frame: Baseline and D28 (end of supplementation)
Change from baseline of Insomnia Severity Index (ISI) score
12 secondary outcomes
Sleep disorder severity over time
Time frame: Baseline and D49 (end of follow-up)
Investigator assessment of sleep disorder symptoms severity
Time frame: Baseline and D28 (end of supplementation)
Investigator assessment of sleep disorder symptoms improvement
Time frame: Baseline and D28 (end of supplementation)
Patient assessment of sleep disorder symptoms improvement after intervention
Time frame: Baseline and D28 (end of supplementation)
Anxiety status
Time frame: Baseline and D28 (end of supplementation)
Anxiety status over time
Time frame: Baseline and D49 (end of follow-up)
Short-form 36 questionnaire (SF36)
Time frame: Baseline and D28 (end of supplementation)
Actimeters
Time frame: Baseline, D7, D14, D21 and D28 (end of supplementation)
Electronic sleep diaries
Time frame: Baseline, D7, D14, D21 and D28 (end of supplementation)
Evolution of sleep troubles
Time frame: Baseline, D28 (end of supplementation) and D49 (end of follow-up)
Addiction
Time frame: Baseline and D49 (end of follow-up)
Adverse events
Time frame: Baseline D7, D14, D21, D28 (end of supplementation) and D49 (end of follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noctesia in people with Sleep Troubles Associated With Anxiety, run by PiLeJe at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep disorder severity (time frame: Baseline and D28 (end of supplementation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.