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

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: Completed
• Conditions: Sleep Disorder (Healthy Volunteers)
• Intervention / Treatment: Drug: MELATONIN (MELATL07959)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Poland
  • Gdańsk, Poland
    • Sanofi Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 73 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Comparison of the sleep quality	Difference in the average score of sleep quality	From baseline to Day 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the average scores of sleep quality	Difference in the average score of sleep quality	From baseline to Day 28
Comparison of time for getting asleep	Difference in the average score of time for getting asleep	From baseline to Day 28
Comparison of sleep time	Difference in the average score of sleep time	From baseline to Day 28
Comparison of number of nocturnal awakening	Difference in the average score of number of nocturnal awakening	From baseline to Day 28
Comparison of number of nightmares	Difference in the average score of number of nightmares	From baseline to Day 28
Comparison of awakening quality	Difference in the average score of awakening quality	From baseline to Day 28
Comparison of mean tiredness	Difference in the average score of mean tiredness	From baseline to Day 28
Adverse events (AEs)	Number of participants with AEs	From baseline to Day 28
Dependency questionnaire	Assessment of product's effects dependency at Day 28	At Day 28

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2017
• Primary Completion (Actual): July 5, 2017
• Study Completion (Actual): July 5, 2017

Study Registration Dates

• First Submitted: April 20, 2018
• First Submitted That Met QC Criteria: April 20, 2018
• First Posted (Actual): May 2, 2018

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Parasomnias; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID 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