SleepPhase 1NCT04093271
Investigating the Efficacy of Rest-ZZZ Formula in Healthy Participants With Difficulty Falling Asleep or Staying a Sleep
A Phase 1 study testing Rest-ZZZ and Active Comparator - Diphenhydramine HCl in people with Sleep and Healthy, run by LifeSeasons Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Rest-ZZZ and Active Comparator - Diphenhydramine HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- 24 Sep 2019to 23 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
- Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
Show all 20Show fewer
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- 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
- Agrees to maintain current sleep schedule throughout the study
- Agrees to stay in the current time zone for the duration of the study
- Agrees to refrain from herbal teas within 2 hours of bedtime, unless currently a part of their night routine for more than 30 days
- Agrees to refrain from over-the-counter (OTC) products to help with sleep
- Agrees to refrain from caffeine intake after 3:00 pm during the study
- Agrees to comply with all study procedures
Who cannot join
- 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
Show all 31Show fewer
- 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
- Controlled and uncontrolled hypo- and hypertension
- Type I and Type II diabetes
- Current employment that calls for shift work or have worked shift work in the last 3 weeks
- Travel across 1 or more-time zones in the last 2 weeks and/or is anticipating more travel
- Clinically significant abnormal laboratory results at screening
- Use of prescribed medications or any other medications used to help with sleep
- Use of OTC medications, supplements, food, drinks or products similar to the comparator or Rest-ZZZ to help with sleep. Chamomile, passion flower, valerian root, lemon balm and hawthorn berry ingested as teas and part of daily routine may be included in the study. However, participants will be required to maintain their current routines of consumption until the completion of the study.
- Evidence or history of clinically significant hematological, renal, endocrine, hepatic, and neurological diseases within the last 5 years as assessed by the QI
- Autoimmune disease or if immune-compromised (i.e. HIV-positive, use of anti-rejection medication, rheumatoid arthritis, Hepatitis B/C-positive)
- Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow-up that is negative. Volunteers with cancer in full remission for more than 5 years after diagnosis are acceptable after review by QI
- Diagnosis of any pineal gland abnormalities or have undergone pinealectomy
- Diagnosis of lower gastrointestinal diseases such as irritable bowel syndrome and inflammatory bowel disease
- Current or history of bleeding disorders
- Surgical procedures which may impact the study outcomes within the past 3 months to be assessed by the QI
- Tobacco use (cigarettes, e-cigarettes, vaporizers, etc.) within 90 days prior to baseline
- Use of recreational marijuana within 30 days prior to baseline
- High alcohol intake (average of >2 standard drinks per day or > 10 standard drinks per week)
- Excessive habitual caffeine consumption (>2 cups coffee or >3 cups caffeinated tea or >2 energy drinks per day) or caffeine intake after 3:00 pm
- Illicit drug use in the past 6 months as assessed by the QI
- Participation in clinical trials within 30 days prior to enrollment
- Blood donation will be assessed on a case-by case basis depending on frequency of donation and hematological and clinical chemistry parameters
- History of any mental illness that might impair the ability of participants to provide written informed consent
- Any other condition, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures, or pose significant risk to the participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Cross-over, Pilot Study to Investigate the Efficacy of Rest-ZZZ Formula in Healthy Participants With Difficulty Falling Asleep or Staying a Sleep
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
- Being tested
- Rest-ZZZ, Active Comparator - Diphenhydramine HCl, Placebo
- Keywords
- Sleep, Healthy, Rest-ZZZ, randomized controlled trial, RCT, dietary supplement, natural health product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rest-ZZZDietary supplement
A dietary supplement containing melatonin, valerian root, chamomile, passion flower, GABA, hawthorn berry, and lemon balm
Active Comparator - Diphenhydramine HClDrug
DIN 02229960 encapsulated for blinding purposes
PlaceboOther
No active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Randomized to consume Rest-ZZZ, comparator, then placebo | Experimental | Each study product will be consumed as 2 capsules daily for 7 days. Randomized to consume the Rest-ZZZ dietary supplement in Study Period 1, Comparator (Diphenhydramine HCl) in Study Period 2, and Placebo in Study Period 3. Receives: Dietary Supplement: Rest-ZZZ; Drug: Active Comparator - Diphenhydramine HCl; Other: Placebo |
| Randomized to consume comparator, placebo, then Rest-ZZZ | Experimental | Each study product will be consumed as 2 capsules daily for 7 days. Randomized to consume the Comparator (Diphenhydramine HCl) in Study Period 1, Placebo in Study Period 2, and the Dietary Supplement, Rest-ZZZ in Study Period 3. Receives: Dietary Supplement: Rest-ZZZ; Drug: Active Comparator - Diphenhydramine HCl; Other: Placebo |
| Randomized to consume placebo, Rest-ZZZ, then comparator | Experimental | Each study product will be consumed as 2 capsules daily for 7 days. Randomized to consume Placebo in Study Period 1, Dietary Supplement, Rest-ZZZ in Study Period 2, and Comparator (Diphenhydramine HCl) in Study Period 3. Receives: Dietary Supplement: Rest-ZZZ; Drug: Active Comparator - Diphenhydramine HCl; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
The SQ Questionnaire will provide an index for the following parameters: sleep efficiency, perceived sleep debt, and sleep difficulty. In the sleep difficulty section, there are 7 questions asking participants to rate on a scale of 1 to 5 (1 = Strongly Disagree, 2 = Disagree, 3 = No Opinion, 4 = Agree, 5 = Strongly agree). There are 7 questions in the sleep-related quality of life asking participants to rate on a scale of 1 to 5 (1 = Strongly Disagree, 2 = Disagree, 3 = No Opinion, 4 = Agree, 5 = Strongly agree). In both cases, a higher score corresponds to more sleep difficulty and worse sleep-related quality of life (one question in the sleep-related quality of life section has reverse scoring).
Measured: 7 days
Secondary outcomes (2)
Comparison between Rest-ZZZ, comparator, and placebo in the change in quality of life assessed by a quality of life questionnaire from pre-supplementation to after 7 days of supplementation
The quality of life questionnaire will be used to measure discomfort and feelings of well being. This questionnaire has 31 questions assessing different areas in quality of life with various scales.
Measured: 7 days
Comparison between Rest-ZZZ, comparator, and placebo in the change in Profile of Mood States (POMS) questionnaire from pre-supplementation to after 7 of supplementation
The POMS index is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials including other exercise related studies. POMS are a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Participants will be instructed by a clinic coordinator to respond to the questionnaire based on the past week.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start24 Sep 2019
- Primary completion23 Dec 2019
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeSeasons Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093271
- Sponsor's protocol ID
- 18RSHL
- Status last verified
- Nov 2019
- First submitted
- 16 Sep 2019
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Cross-over, Pilot Study to Investigate the Efficacy of Rest-ZZZ Formula in Healthy Participants With Difficulty Falling Asleep or Staying a Sleep
- ClinicalTrials.gov ID
- NCT04093271
- Acronym / sponsor ID
- 18RSHL
- Keywords
- Sleep, Healthy, Rest-ZZZ, randomized controlled trial, RCT, dietary supplement, natural health product
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- LifeSeasons Inc.Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 18 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Randomized to consume Rest-ZZZ, comparator, then placebo | Experimental | Dietary Supplement: Rest-ZZZ, Drug: Active Comparator - Diphenhydramine HCl, Other: PlaceboEach study product will be consumed as 2 capsules daily for 7 days. Randomized to consume the Rest-ZZZ dietary supplement in Study Period 1, Comparator (Diphenhydramine HCl) in Study Period 2, and Placebo in Study Period 3. |
| Randomized to consume comparator, placebo, then Rest-ZZZ | Experimental | Dietary Supplement: Rest-ZZZ, Drug: Active Comparator - Diphenhydramine HCl, Other: PlaceboEach study product will be consumed as 2 capsules daily for 7 days. Randomized to consume the Comparator (Diphenhydramine HCl) in Study Period 1, Placebo in Study Period 2, and the Dietary Supplement, Rest-ZZZ in Study Period 3. |
| Randomized to consume placebo, Rest-ZZZ, then comparator | Experimental | Dietary Supplement: Rest-ZZZ, Drug: Active Comparator - Diphenhydramine HCl, Other: PlaceboEach study product will be consumed as 2 capsules daily for 7 days. Randomized to consume Placebo in Study Period 1, Dietary Supplement, Rest-ZZZ in Study Period 2, and Comparator (Diphenhydramine HCl) in Study Period 3. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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,
Key exclusion criteria (31 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rest-ZZZA dietary supplement containing melatonin, valerian root, chamomile, passion flower, GABA, hawthorn berry, and lemon balm | Dietary supplement | Randomized to consume Rest-ZZZ, comparator, then placebo, Randomized to consume comparator, placebo, then Rest-ZZZ, Randomized to consume placebo, Rest-ZZZ, then comparator |
| Active Comparator - Diphenhydramine HClDIN 02229960 encapsulated for blinding purposes | Drug | Randomized to consume Rest-ZZZ, comparator, then placebo, Randomized to consume comparator, placebo, then Rest-ZZZ, Randomized to consume placebo, Rest-ZZZ, then comparator |
| PlaceboNo active ingredients | Other | Randomized to consume Rest-ZZZ, comparator, then placebo, Randomized to consume comparator, placebo, then Rest-ZZZ, Randomized to consume placebo, Rest-ZZZ, then comparator |
Primary outcome
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
Time frame: 7 days
The SQ Questionnaire will provide an index for the following parameters: sleep efficiency, perceived sleep debt, and sleep difficulty. In the sleep difficulty section, there are 7 questions asking participants to rate on a scale of 1 to 5 (1 = Strongly Disagree, 2 = Disagree, 3 = No Opinion, 4 = Agree, 5 = Strongly agree). There are 7 questions in the sleep-related quality of life asking participants to rate on a scale of 1 to 5 (1 = Strongly Disagree, 2 = Disagree, 3 = No Opinion, 4 = Agree, 5 = Strongly agree). In both cases, a higher score corresponds to more sleep difficulty and worse sleep-related quality of life (one question in the sleep-related quality of life section has reverse scoring).
2 secondary outcomes
Comparison between Rest-ZZZ, comparator, and placebo in the change in quality of life assessed by a quality of life questionnaire from pre-supplementation to after 7 days of supplementation
Time frame: 7 days
Comparison between Rest-ZZZ, comparator, and placebo in the change in Profile of Mood States (POMS) questionnaire from pre-supplementation to after 7 of supplementation
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
Related trials for Sleep
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rest-ZZZ and Active Comparator - Diphenhydramine HCl in people with Sleep and Healthy, run by LifeSeasons Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.