Sleep QualityNCT05368909
Clinical Study to Assess a Dietary Supplement on Sleep Health and Quality
A study testing Sleep Supplement in people with Sleep Quality and Sleep Health, run by 4Life Research, LLC at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the effects of a proprietary oral supplement on the sleep health and quality of people with sleep problems. It is a double-blinded placebo-controlled crossover clinical study. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Sleep Health
- What is being tested?
- Sleep Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2021to 31 May 2022
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smokers
- Judged by the Investigator to be in general good health on the basis of medical history
- Willing to wash out of all dietary supplements, essential oils, and non-prescription sleep aids or Rx sleep aids for the duration of the study
- Insomnia Severity Index score of ≥ 8
- Must agree to maintain the same eating, exercise, and sleep arrangements for the whole duration of the study
Who cannot join
- Pregnant and/or lactating women
- Known allergy or adverse reaction to ingredients in the product: Tri Factor (bovine colostrum and egg yolk extracts), Ashwagandha root extract, Lavender, Pyridoxal-5-Phosphate, Melatonin, gamma aminobutyric acid (GABA) or Magnesium
- Prescription sedative or psychoactive (including anti-depressant) medication use
- Diagnosis of a sleep disorder (e.g., sleep apnea, periodic limb movement disorder, etc.) or high clinical probability of another sleep disorder based on sleep history
- A clinically unstable medical condition as defined by a new diagnosis or change in medical management in the previous 4 months (e.g., myocardial infarction, congestive heart failure, Cheyne-Stokes breathing, unstable angina, thyroid disease, depression or psychosis, ventricular arrhythmias, cirrhosis, surgery, or recently diagnosed cancer)
- Routine consumption of more than 2 alcoholic beverages per day or consumption of caffeine past 2 PM for the duration of the study
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- Illicit drug use
- Use of prescription stimulants (modafinil, dextroamphetamine, etc.)
- Use of prescription medications known to affect sleep (antidepressants, anti-anxiety, opioids, alpha-blockers, beta-blockers, corticosteroids, ACE inhibitors, angiotensin II-receptor blockers, cholinesterase inhibitors, allergy medication, asthma medication, glucosamine and chondroitin, statins, anti-smoking or thyroid medication, muscle relaxants, anticonvulsants)
- Unable to perform tests due to inability to communicate verbally, inability to write and read in English; less than a 10th grade reading level; visual, hearing or upper extremity motor deficit
- Night shift workers in situations or occupations where they regularly experience jet lag, or have irregular work schedules by history over the last 6 months
- Unwilling to consume or unable to swallow capsules/tablets
- Previous exposure to this product in earlier testing phases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Effects of a Dietary Supplement on the Sleep Health and Sleep Quality of People With Sleep Problems: A Randomized, Double-blind, Placebo-controlled, Crossover Design Study
The primary objective of this study is to evaluate the effects of a proprietary oral supplement on the sleep health and quality of people with sleep problems. It is a double-blinded placebo-controlled crossover clinical study.
- Conditions
- Sleep Quality, Sleep Health
- Being tested
- Sleep Supplement, Placebo
- Keywords
- Sleep Health, Sleep Quality, Melatonin, Lavender essential oil, GABA
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep SupplementDietary supplement
Proprietary sleep formula containing Tri Factor, Ashwagandha root extract, Lavender, Pyridoxal-5-Phosphate, Melatonin, gamma aminobutyric acid (GABA) and Magnesium.
PlaceboDietary supplement
Placebo product
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 before Cross Over | Experimental | Participants were randomized and divided into two groups: Supplement Group and Placebo Group. In this Arm 1, participants first go through a 1-week washout period, and then take either Supplement or Placebo as assigned for 2 week. Receives: Dietary Supplement: Sleep Supplement; Dietary Supplement: Placebo |
| Arm 2 after Cross Over | Experimental | In Arm 2, Supplement Group and Placebo Group cross over. After a 1-week washout period, and both group will take whatever product they did not take in Arm 2, for 2 week. Receives: Dietary Supplement: Sleep Supplement; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saliva Melatonin level changes
Samples taken before bedtime at night and 2 hours after wakeup the next morning. A total of 8 samples were taken for each subject: (2) right after first washout, (2) right after Arm 1, (2) right after the second washout, (2) right after Arm 2.
Measured: 6 weeks
Insomnia Severity Index Score
A scale used to measure the severity of insomnia. Total score categories:
0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
Measured: 6 weeks
Secondary outcomes (4)
Sleep Onset Latency
Sleep latency, or sleep onset latency, is the time it takes a person to fall asleep after turning the lights out.
Measured: 6 weeks
Total Sleep Time
Total time a person spends asleep over a given night
Measured: 6 weeks
Sleep Efficiency
Sleep efficiency is typically referring to the percentage of time a person spends asleep at night. To calculate this, you take a ratio of the total amount of time a person was asleep on a given night divided by the total amount of time they spent in bed, then multiply that by 100 to create a percentage.
Measured: 6 weeks
Leeds Sleep Evaluation Questionnaire (LSEQ) Score
A 10-item, subjective, self-report measure, the LSEQ was designed to assess changes in sleep quality over the course of a psychopharmacological treatment intervention. The scale evaluates four domains: ease of initiating sleep, quality of sleep, ease of waking, and behavior following wakefulness. Total LSEQ Score ranges from 0 to 100, with 100 being the worst sleep quality and health overall.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start16 Dec 2021
- Primary completion28 Mar 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- 4Life Research, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368909
- Sponsor's protocol ID
- 4Life-Sleep
- Status last verified
- Jul 2022
- First submitted
- 2 May 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effects of a Dietary Supplement on the Sleep Health and Sleep Quality of People With Sleep Problems: A Randomized, Double-blind, Placebo-controlled, Crossover Design Study
- ClinicalTrials.gov ID
- NCT05368909
- Acronym / sponsor ID
- 4Life-Sleep
- Conditions
- Sleep Quality, Sleep Health
- Keywords
- Sleep Health, Sleep Quality, Melatonin, Lavender essential oil, GABA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- 4Life Research, LLCIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 10 May 2022 (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.
The primary objective of this study is to evaluate the effects of a proprietary oral supplement on the sleep health and quality of people with sleep problems. It is a double-blinded placebo-controlled crossover clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 before Cross Over | Experimental | Dietary Supplement: Sleep Supplement, Dietary Supplement: PlaceboParticipants were randomized and divided into two groups: Supplement Group and Placebo Group. In this Arm 1, participants first go through a 1-week washout period, and then take either Supplement or Placebo as assigned for 2 week. |
| Arm 2 after Cross Over | Experimental | Dietary Supplement: Sleep Supplement, Dietary Supplement: PlaceboIn Arm 2, Supplement Group and Placebo Group cross over. After a 1-week washout period, and both group will take whatever product they did not take in Arm 2, for 2 week. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Non-smokers
- Judged by the Investigator to be in general good health on the basis of medical history
- Willing to wash out of all dietary supplements, essential oils, and non-prescription sleep aids or Rx sleep aids for the duration of the study
- Insomnia Severity Index score of ≥ 8
- Must agree to maintain the same eating, exercise, and sleep arrangements for the whole duration of the study
Key exclusion criteria (13 listed)
- Pregnant and/or lactating women
- Known allergy or adverse reaction to ingredients in the product: Tri Factor (bovine colostrum and egg yolk extracts), Ashwagandha root extract, Lavender, Pyridoxal-5-Phosphate, Melatonin, gamma aminobutyric acid (GABA) or Magnesium
- Prescription sedative or psychoactive (including anti-depressant) medication use
- Diagnosis of a sleep disorder (e.g., sleep apnea, periodic limb movement disorder, etc.) or high clinical probability of another sleep disorder based on sleep history
- A clinically unstable medical condition as defined by a new diagnosis or change in medical management in the previous 4 months (e.g., myocardial infarction, congestive heart failure, Cheyne-Stokes breathing, unstable angina, thyroid disease, depression or psychosis, ventricular arrhythmias, cirrhosis, surgery, or recently diagnosed cancer)
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 |
|---|---|---|
| Sleep SupplementProprietary sleep formula containing Tri Factor, Ashwagandha root extract, Lavender, Pyridoxal-5-Phosphate, Melatonin, gamma aminobutyric acid (GABA) and Magnesium. | Dietary supplement | Arm 1 before Cross Over, Arm 2 after Cross Over |
| PlaceboPlacebo product | Dietary supplement | Arm 1 before Cross Over, Arm 2 after Cross Over |
Primary outcome
Saliva Melatonin level changes
Time frame: 6 weeks
Samples taken before bedtime at night and 2 hours after wakeup the next morning. A total of 8 samples were taken for each subject: (2) right after first washout, (2) right after Arm 1, (2) right after the second washout, (2) right after Arm 2.
Insomnia Severity Index Score
Time frame: 6 weeks
A scale used to measure the severity of insomnia. Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
4 secondary outcomes
Sleep Onset Latency
Time frame: 6 weeks
Total Sleep Time
Time frame: 6 weeks
Sleep Efficiency
Time frame: 6 weeks
Leeds Sleep Evaluation Questionnaire (LSEQ) Score
Time frame: 6 weeks
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 12 Jul 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Supplement in people with Sleep Quality and Sleep Health, run by 4Life Research, LLC at 1 site in United States.
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 5 inclusion and 13 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 12 Jul 2022. 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 United States. 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.
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?
Saliva Melatonin level changes (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 12 Jul 2022.