Clinical trial NCT03514732: Study to Evaluate Improvements of the Quality of Sleep With NOVANUIT® Triple Action in Healthy Volunteers With Sleep Disorders
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sleep Disorder (Healthy Volunteers)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2018-05-02
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of the sleep quality
timeFrame: From baseline to Day 21
Secondary outcomes:
measure: Comparison of the average scores of sleep quality
timeFrame: From baseline to Day 28
measure: Comparison of time for getting asleep
timeFrame: From baseline to Day 28
measure: Comparison of sleep time
timeFrame: From baseline to Day 28
measure: Comparison of number of nocturnal awakening
timeFrame: From baseline to Day 28
measure: Comparison of number of nightmares
timeFrame: From baseline to Day 28
measure: Comparison of awakening quality
timeFrame: From baseline to Day 28
measure: Comparison of mean tiredness
timeFrame: From baseline to Day 28
measure: Adverse events (AEs)
timeFrame: From baseline to Day 28
measure: Dependency questionnaire
timeFrame: At Day 28
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Sanofi Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: