SleepNCT05971771
Study to Assess Impact of Dietary Supplement on Sleep Health
A study testing Treatment in people with Sleep, run by Pharmanex.
Trial summary
Sleep is essential for health and wellness. Sleep disruption can occur due to emotional stress, advancing age, hormonal imbalance, medications, and many other causes, some of which are presently unknown. Most pharmaceutical sleep products artificially induce sedation without providing quality sleep. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 31 Dec 2023
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject is male or female 20-60 years of age at the time of informed consent.
- Recorded baseline BMI is ≥18.5 and ≤29.9 kg/m2.
- A score of 5 or higher on the Pittsburgh Sleep Quality Index.
- Willing and able to give informed consent
- Willing to maintain consistent diet and physical activity through the study period.
- Willing to limit alcohol consumption to ≤14 drinks per week, no more than 4 drinks at a time, and no more than 1 drink within 4h of bedtime.
- Willing to limit caffeine consumption to no more than 4 servings per day and no caffeine within 6h of bedtime.
Who cannot join
- Could not or did not want to participate in clinical study.
- Taken nutritional supplements for sleep or stress in the previous 6 months.
- Have received non-pharmacological treatment for sleep disorders (eg. Cognitive behavioral therapy, relation therapy) in previous 6 months
- Any known allergy or intolerance to any of the ingredients contained in supplement.
- Planned surgical procedure during the course of the study.
- Used nicotine in the past 6 months.
Show all 17Show fewer
- Have a major psychiatric disorder as determined by the Mini International Neuropsychiatric Inventory
- A history of unconventional sleep pattern, a diagnosed sleep disorder, or chronic medical condition that could affect energy/fatigue levels.
- Consume more than 400mg of caffeine per day in the past 2 weeks.
- Used any psychotropic medications, stimulants, cannabis, non-registered drug products, or illicit substances in the past 4 weeks.
- At risk of drug or alcohol abuse
- Used any sleep aids in the past 2 weeks.
- Employed in night shift work or rotational shift work
- Currently pregnant, nursing, planning to become pregnant, or unwilling to use a medically approved form of contraception will be excluded.
- Individuals who sleep more than 10 hours.
- Typically take a nap during the day.
- Those planning travel or vacation during the study period.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Single Center Pilot Study to Assess the Impact of Sleep Supplement on Sleep Health
Sleep is essential for health and wellness. Sleep disruption can occur due to emotional stress, advancing age, hormonal imbalance, medications, and many other causes, some of which are presently unknown. Most pharmaceutical sleep products artificially induce sedation without providing quality sleep. Thus, a need exists for safe dietary supplement to promote and support healthy sleep that will encourage restful sleep. This study will examine the efficacy, tolerance, and safety of sleep supplement as compared to a placebo.
- Conditions
- Sleep
- Being tested
- Placebo, Treatment
- Keywords
- Sleep, Alertness, Restfulness, Dietary AND Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Also called Placebo Supplement
Two softgels to be taken with water that is to be consumed approximately 30-60 minutes before going to bed
TreatmentDietary supplement
Also called Supplement for supporting sleep
14mg saffron extract and 250mg magnesium citrate that is powder that is mixed in 3-4 oz of water and consumed 30-60 minutes before going to bed
| Study group | Role | What they receive |
|---|---|---|
| Active: Sleep Supplement containing Magnesium and Saffron Extract | Experimental | Powder that is to be mixed into 3oz. of water, 30-60 minutes before going to bed Receives: Dietary Supplement: Treatment |
| Placebo | Placebo comparator | Placebo that is 2 softgels that will be taken with water, 30-60 minutes prior to going to bed. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline sleep quality index
Change from baseline in validated Pittsburgh Sleep Quality Index (0-21, higher number indicates poorer quality)
Measured: Baseline, Day 1, Day 7, Day 28
Change from baseline sleep duration and quality from diary
Change from baseline with Daily Sleep Diary
Measured: Baseline and Daily for 28 days
Secondary outcomes (5)
Change from baseline perceived stress scale
Change from baseline with validated perceived stress questionnaire
Measured: Baseline, Day 1, Day 7, Day 28
Change from baseline Insomnia severity index
Change from baseline using validated Insomnia Severity Index (0-28, higher number indicates more severe insomnia)
Measured: Baseline, Day 1, Day 7, Day 28
Change from baseline in restorative sleep as measured by Restorative Sleep Questionnaire (RSQ)
Change from baseline using restorative sleep questionnaire as measured by Restorative Sleep Questionnaire (RSQ) that is a 9-item scale/question assessing symptoms over the last week. The total score ranges from 0 to 100, with higher scores indicating better restorative sleep
Measured: Baseline, Day 1, Day 7, Day 28
Change from baseline in mood
Change from baseline using abbreviated Profile of Mood States (POMS) is a widely used questionnaire of 24 items and four scales. Total numbers range from 0-not at all to 4-very strong
Measured: Baseline, Day 1, Day 7, Day 28
Change from baseline in skin attributes
Change from baseline in skin attributes using 1-5 scale (1 strongly disagree to 5 strongly agree) with questionnaire regarding skin appearance (youthfulness, glow, evenness, hydration, etc)
Measured: Baseline, Day 7, and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Aug 2023 (estimated)
- Primary completion30 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blind, placebo controlled, parallel designed study in healthy subjects
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmanex
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dermatology Consulting Services, High Point NC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971771
- Sponsor's protocol ID
- DCS-7-23
- Status last verified
- Jun 2023
- First submitted
- 15 Jun 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- 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 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Single Center Pilot Study to Assess the Impact of Sleep Supplement on Sleep Health
- ClinicalTrials.gov ID
- NCT05971771
- Acronym / sponsor ID
- DCS-7-23
- Conditions
- Sleep
- Keywords
- Sleep, Alertness, Restfulness, Dietary AND Supplement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- PharmanexIndustry (pharma, biotech, devices)
- Collaborators
- Dermatology Consulting Services, High Point NC
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 2 Aug 2023 (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.
Sleep is essential for health and wellness. Sleep disruption can occur due to emotional stress, advancing age, hormonal imbalance, medications, and many other causes, some of which are presently unknown. Most pharmaceutical sleep products artificially induce sedation without providing quality sleep. Thus, a need exists for safe dietary supplement to promote and support healthy sleep that will encourage restful sleep. This study will examine the efficacy, tolerance, and safety of sleep supplement as compared to a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blind, placebo controlled, parallel designed study in healthy subjects
| Arm | Type | Receives |
|---|---|---|
| Active: Sleep Supplement containing Magnesium and Saffron Extract | Experimental | Dietary Supplement: TreatmentPowder that is to be mixed into 3oz. of water, 30-60 minutes before going to bed |
| Placebo | Placebo comparator | Other: PlaceboPlacebo that is 2 softgels that will be taken with water, 30-60 minutes prior to going to bed. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The subject is male or female 20-60 years of age at the time of informed consent.
- Recorded baseline BMI is ≥18.5 and ≤29.9 kg/m2.
- A score of 5 or higher on the Pittsburgh Sleep Quality Index.
- Willing and able to give informed consent
- Willing to maintain consistent diet and physical activity through the study period.
Key exclusion criteria (17 listed)
- Could not or did not want to participate in clinical study.
- Taken nutritional supplements for sleep or stress in the previous 6 months.
- Have received non-pharmacological treatment for sleep disorders (eg. Cognitive behavioral therapy, relation therapy) in previous 6 months
- Any known allergy or intolerance to any of the ingredients contained in supplement.
- Planned surgical procedure during the course of the study.
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 |
|---|---|---|
| PlaceboAlso: Placebo SupplementTwo softgels to be taken with water that is to be consumed approximately 30-60 minutes before going to bed | Other | Placebo |
| TreatmentAlso: Supplement for supporting sleep14mg saffron extract and 250mg magnesium citrate that is powder that is mixed in 3-4 oz of water and consumed 30-60 minutes before going to bed | Dietary supplement | Active: Sleep Supplement containing Magnesium and Saffron Extract |
Primary outcome
Change from baseline sleep quality index
Time frame: Baseline, Day 1, Day 7, Day 28
Change from baseline in validated Pittsburgh Sleep Quality Index (0-21, higher number indicates poorer quality)
Change from baseline sleep duration and quality from diary
Time frame: Baseline and Daily for 28 days
Change from baseline with Daily Sleep Diary
5 secondary outcomes
Change from baseline perceived stress scale
Time frame: Baseline, Day 1, Day 7, Day 28
Change from baseline Insomnia severity index
Time frame: Baseline, Day 1, Day 7, Day 28
Change from baseline in restorative sleep as measured by Restorative Sleep Questionnaire (RSQ)
Time frame: Baseline, Day 1, Day 7, Day 28
Change from baseline in mood
Time frame: Baseline, Day 1, Day 7, Day 28
Change from baseline in skin attributes
Time frame: Baseline, Day 7, and Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment in people with Sleep, run by Pharmanex.
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 7 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zoe D Diana, MD (336-841-2040, zdraelos@northstate.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline sleep quality index (time frame: Baseline, Day 1, Day 7, Day 28). 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 2 Aug 2023.