Study to Evaluate Improvements of the Quality of Sleep With NOVANUIT® Triple Action in Healthy Volunteers With Sleep Disorders

April 21, 2022 updated by: Sanofi

An Open Label, Single Arm, Exploratory Study to Estimate the Range of Improvement of the Quality of Sleep With NOVANUIT® Triple Action in Subjects With Mild to Moderate Sleep Disorders

Primary Objective:

To estimate the range of improvement of NOVANUIT® triple action on sleep quality global score.

Secondary Objectives:

  • To estimate the range of improvement of NOVANUIT® triple action on following parameters: time for getting asleep, sleep time, number of nocturnal awakening, number of nightmares, sleep quality (score from 0 to 10), and mean tiredness during the day (score from 0 to 10).
  • To estimate persistency of NOVANUIT® triple action effects after end of study product consumption.
  • To assess dependency to NOVANUIT® triple action after study product cessation.
  • To assess tolerance of NOVANUIT® triple action during the study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study participation duration for each participant will be 4 weeks including a 2-week treatment period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Gdańsk, Poland
        • Sanofi Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria :

  • Healthy men or women volunteers, aged from 20 to 75 years included at the moment of the inclusion visit.
  • Subject with Body Mass Index (BMI) between 18.5 and 29.9 kg/m² (limits included).
  • Good general health (based on subject interview about his/her medical history and on clinical exam realized by investigator).
  • Subject willing to follow diet recommendations in accordance with hygiene and dietary advice defined in the protocol.
  • Subject suffering from mild to moderate sleep disorders assessed by Insomnia Severity Index (ISI) questionnaire completed during the selection and presenting a score between 7 and 22 (limits excluded).
  • Subject covered by a social security or insurance.

Exclusion criteria:

  • Subject having consumed medications for sleep disorders (sleeping pills) during the 6 months previous the inclusion visit and throughout the study duration.
  • Subject having consumed dietary supplements for sleep disorders during the 3 months previous to inclusion visit and throughout the study duration.
  • Subject presenting history of severe chronic disease (cancer, HIV, renal or hepatic failure, hepatic disorders, inflammatory digestive and known malabsorption diseases, arthritis or chronic respiratory insufficiency, etc.) found to be inconsistent for the study follow up by investigator.
  • Subject suffering from a chronic or acute pathology causing sleep disorders.
  • Subject consuming products with impact on sleep deterioration at the moment of inclusion visit and throughout the study duration, belong to investigator.
  • Subject having undergone general anesthesia during the month previous to inclusion visit.
  • Subject suffering from eating disorders (anorexia, bulimia, etc.).
  • Subject consuming more than 1.5 packet of tobacco per day (30 cigarettes/day or 27 mg of nicotine/day in electronic cigarette).
  • Subject with history of known dependency to drugs or alcohol (consuming more than 3 alcohol units per day). In this study, 1 unit of alcohol is defined as 250 mL of beer, 100 mL of wine or 30 mL of spirits.
  • Subject having under the care a child who as constant sleep troubles through the night.
  • Subject with irregular working hours (day/night shifts, day/night duties, work trip during the study, etc.).
  • Subject taking part in another clinical trial simultaneously and/or in the month previous to inclusion visit and/or being in exclusion period of a previous clinical trial.
  • Woman planning to be pregnant soon, actually pregnant or lactating.
  • Woman without efficient contraceptive method such as: hormonal contraception (including patch, contraceptive ring, etc.), uterine device or any other mechanic contraceptive method, or condom or diaphragm or spermicide, throughout the duration of the study.
  • Subject with sensitivity or known allergy to the product used in the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Novanuit® Triple Action
2 capsules of Novanuit® Triple Action once daily for 2 weeks, 30 minutes to 1 hour before bedtime.
Drug: MELATONIN (MELATL07959)
Pharmaceutical form:Capsule Route of administration: Oral

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comparison of the sleep quality
Time Frame: From baseline to Day 21
Difference in the average score of sleep quality
From baseline to Day 21

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison of the average scores of sleep quality
Time Frame: From baseline to Day 28
Difference in the average score of sleep quality
From baseline to Day 28
Comparison of time for getting asleep
Time Frame: From baseline to Day 28
Difference in the average score of time for getting asleep
From baseline to Day 28
Comparison of sleep time
Time Frame: From baseline to Day 28
Difference in the average score of sleep time
From baseline to Day 28
Comparison of number of nocturnal awakening
Time Frame: From baseline to Day 28
Difference in the average score of number of nocturnal awakening
From baseline to Day 28
Comparison of number of nightmares
Time Frame: From baseline to Day 28
Difference in the average score of number of nightmares
From baseline to Day 28
Comparison of awakening quality
Time Frame: From baseline to Day 28
Difference in the average score of awakening quality
From baseline to Day 28
Comparison of mean tiredness
Time Frame: From baseline to Day 28
Difference in the average score of mean tiredness
From baseline to Day 28
Adverse events (AEs)
Time Frame: From baseline to Day 28
Number of participants with AEs
From baseline to Day 28
Dependency questionnaire
Time Frame: At Day 28
Assessment of product's effects dependency at Day 28
At Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 5, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 5, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MELATL07959
  • U1111-1195-6610 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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