Investigating the Efficacy of Rest-ZZZ Formula in Healthy Participants With Difficulty Falling As… (NCT04093271) | Clinical Trial Compass
CompletedPhase 1
Investigating the Efficacy of Rest-ZZZ Formula in Healthy Participants With Difficulty Falling Asleep or Staying a Sleep
Canada27 participantsStarted 2019-09-24
Plain-language summary
A randomized, double-blind, placebo-controlled, cross-over pilot study to investigate the efficacy of Rest-ZZZ in healthy participants with difficulty falling asleep or staying a sleep. The study will have 3 study periods. During each study period, eligible participants will consume either Rest-ZZZ, comparator product, or placebo for 7 days during each study period (1 product per study period), with a 1-week washout period in between each period. The primary objective is the comparison in sleep quality using a sleep quality questionnaire from pre-supplement to Day 7 between the Rest-ZZZ, comparator, and placebo. Other study outcomes include the change in quality of life, profile of mood states (POMS), and safety outcomes such as vital signs, clinical chemistry and hematological markers
Who can participate
Age range25 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Has given voluntary, written, informed consent to participate in the study
✓. Males and females 25-65 years of age, inclusive
✓. BMI of 18-32.5 kg/m2, inclusive
✓. Difficulty in falling asleep (taking longer than 30 minutes to fall asleep) or staying asleep, with 2 or more waking episodes in a 7-day period for at least 2 weeks
✓. Females participant is not of child bearing potential, defined as females who have had a hysterectomy or bilateral oophorectomy, bilateral tubal ligation, total endometrial ablation or are post-menopausal (natural or surgically with \> 1 year since last menstruation) or,
✓. Healthy as determined by laboratory results and medical history and by QI assessment
✓. Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
✓. Agrees to maintain normal diet and exercise routine throughout the study
Exclusion criteria
What they're measuring
1
Comparison of change in sleep quality assessed by the sleep quality (SQ) questionnaire between Rest-ZZZ, comparator, and placebo from pre-supplementation to after 7 days of supplementation
. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
✕. Anticipated problems or allergies to any active or inactive ingredients in the investigational products as well as other flowers in the Asteraceae/Compositae family
✕. Previous diagnosis of a sleep disorder or use of continuous positive air pressure (C-PAP)
✕. Menopausal women with hot flashes
✕. Registered with the Canadian National Institute for the Blind (CNIB) and considered as legally blind
✕. Currently experiencing vivid nightmares or sleepwalking
✕. Have unstable medical conditions such as heart failure, pneumonia, chronic obstructive pulmonary disease (COPD), reflux/gastroesophageal reflux disease (GERD), restless leg syndrome, chronic pain, or disruptive sleep for medical reasons
✕. Chronic conditions such as asthma, heartburn, and migraines that consistently interfere with sleep