The aim of this study is to determine the impact of a probiotic formulation on subjective sleep patterns. It is hypothesized that participants given the probiotics will improve their sleep patterns compared to participants receiving placebo.
Participants with symptoms of insomnia and work-related stress will be recruited to participate in a randomized, placebo-controlled, double-blind interventional study for approximately 15 since the signature of the informed consent. Participants will first be seen at the Screening visit when they will be administered several questionnaires to determine eligibility (assessing symptoms of insomnia, work-related stress, psychological distress and other sleep disorders). Participants will receive a 2-week sleep journal and an actigraphy to record their sleep patterns. At visit 2 returning participants will be randomized to receive probiotics or placebo for the following 12 weeks. During this visit, participants will be administered questionnaires assessing sleep quality, work-related productivity, quality of life, and mood. Participants will also be asked to bring to site a stool sample and saliva samples. Participants will be asked to return at 6 weeks for visit 3. During this visit participants will be administered questionnaires (insomnia, sleep quality, work-related stress and productivity, quality of life, mood and psychological distress). They will also bring two saliva samples. Two weeks prior to visit 4, participants will be asked to complete another sleep journal and be dispensed another actigraphy which shall be returned at visit 4. Lastly, participants will return on for visit 4 at week 12 in which the same questionnaires as visit 3 will be administered. Participants will also be asked to bring to site another stool sample and two saliva samples.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
70
Participants will be asked to take one capsule daily, containing 3 billion CFU of the probiotics.
Participants will be asked to take a placebo capsule daily.
Centre d'étude des troubles du sommeil, Centre de recherche CERVO/BRAIN
Québec, Canada
Symptoms of insomnia
Comparison of sleep quality assessed by the Insomnia Severity Index among probiotic versus placebo
Time frame: 12 weeks
Symptoms of insomnia (progressive treatment)
Comparison of sleep quality assessed by the Insomnia Severity Index among probiotics versus placebo
Time frame: 6 weeks
Objective assessment of sleep: Sleep Latency
Comparison of sleep latency recorded by actigraphy of probiotic versus placebo
Time frame: 12 weeks
Objective assessment of sleep: Sleep Efficiency
Comparison of sleep efficiency recorded by actigraphy of probiotic versus placebo
Time frame: 12 weeks
Objective assessment of sleep: Wake after sleep onset (WASO)
Comparison of WASO recorded by actigraphy of probiotic versus placebo
Time frame: 12 weeks
Subjective sleep patterns
Comparison of sleep quality, assessed via Visual Analogue Scale (0 to 12; higher scores indicate worse sleep patterns), among probiotics versus placebo
Time frame: 12 weeks
Subjective sleep patterns (progressive treatment)
Comparison of sleep quality, assessed via Visual Analogue Scale (0 to 12; higher scores indicate worse sleep patterns), among probiotics versus placebo
Time frame: 6 weeks
Work-related stress
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Comparison of overall score obtained at the Effort-Reward Imbalance (ERI; scores below 0.8 denote higher reward) among probiotics versus placebo
Time frame: 12 weeks
Work Productivity
Comparison of overall score obtained at the Work Productivity and Activity Impairment (WPAI; 0% to 100%, with higher scores indicating higher impairment and lower productivity) questionnaire among probiotics versus placebo groups.
Time frame: 12 weeks
Change on Quality of life
Comparison of overall score obtained at the questionnaires WHOQOL-Bref (0 to 100; higher scores denote higher quality of life) and Kessler 10 (K10; 5 - no psychological distress to 50 - high psychological distress) among probiotics versus placebo groups.
Time frame: 12 weeks
Mood
Comparison of overall score obtained at the HADS questionnaire (0 - no mood disorder to 21 - responder likely suffers depression and/or anxiety) among probiotics versus placebo groups.
Time frame: 12 weeks
Levels of sleep-related hormones
Comparison of the cortisol and melatonin quantified from saliva samples among probiotics versus placebo
Time frame: 12 weeks
Safety of intervention (number of Serious and Adverse events)
Comparison of the number of adverse events and serious adverse events reported by participants randomized to receive probiotics compared to those receiving placebo.
Time frame: 12 weeks