SleepNCT06146712
A Single-Group Study to Examine the Efficacy of a Melatonin Lotion With Magnesium to Improve Sleep Quality and Quantity
A study testing Asutra's 'Dream the night away' nighttime lotion in people with Sleep, run by Asutra at 1 site in United States.
Trial summary
This study will evaluate the efficacy of Asutra's 'Dream the night away' nighttime lotion with melatonin and magnesium on sleep health in terms of quantity, quality, ease of falling asleep or falling back asleep after waking in the night, and grogginess upon waking. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Asutra's 'Dream the night away' nighttime lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2023to 2 Oct 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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged 18-59.
- Must agree to not use any other sleep aids including prescriptions, supplements, or melatonin products during the study or 28 days prior to Baseline.
- Has favorable sleep conditions (a dark, quiet room to sleep in and is not woken up regularly throughout the night due to personal circumstances e.g. by a baby).
- Willing to maintain their standard sleep pattern and activity level for the duration of the study.
- Be generally healthy and not living with any uncontrolled chronic disease. Willing and able to supply and use their own sleep tracking device.
Who cannot join
- Diagnosed with any chronic sleep condition including insomnia, narcolepsy, or sleep apnea.
- Has extremely sensitive/irritable skin or diagnosed skin conditions.
- Has poor sleep hygiene as a result of specific personal circumstances e.g. new mothers.
- Women who are pregnant, breastfeeding, or attempting to become pregnant.
- Anyone unwilling or unable to follow the study protocol.
- Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
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- Is currently undergoing, or planning to to undergo any sleep-related procedures in the next three weeks.
- A history of severe allergic reactions including but not limited to any of the product's ingredients.
- Heavy drinkers or drug users. A heavy drinker is considered to be a woman who drinks 8 or more alcoholic drinks per week or a man who drinks 15 or more alcoholic drinks per week.
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the efficacy of Asutra's 'Dream the night away' nighttime lotion with melatonin and magnesium on sleep health in terms of quantity, quality, ease of falling asleep or falling back asleep after waking in the night, and grogginess upon waking. The study will be conducted as a virtual single-group trial in which all 35 participants will use the test product. This study will last 3 weeks, and participants will use the product daily (each night 30 minutes before bedtime for 20 nights). Participants will use a sleep tracker to monitor their sleep for a week at Baseline (before commencing the trial) and nightly throughout the trial. Participants will complete study-specific questionnaires at Baseline, and after first use, 3 days, 1 week, 2 weeks, and 3 weeks, in which they will also record the results from their sleep tracker.
- Conditions
- Sleep
- Being tested
- Asutra's 'Dream the night away' nighttime lotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asutra's 'Dream the night away' nighttime lotionOther
Product contains Water (Aqua), Magnesium Chloride, Dimethyl Sulfone (MSM), Prunus Amygdalus Dulcis (Sweet Almond) Oil, Butyrospermum Parkii (Shea Butter), Sodium Lactate, Cetearyl Alcohol, Glyceryl Stearate Citrate, Glycerin, Undecane, Cetyl Palmitate, Polyglyceryl-3 Diisostearate, Pentylene Glycol, Glyceryl Stearate, Magnesium Sulfate, Melatonin, Tridecane, Potassium Chloride, Sodium Chloride, Calcium Chloride, Tocopheryl Acetate, Xanthan Gum, Hydroxyacetophenone, Sodium Hydroxide, Cymbopogon Flexuosus (East-Indian Lemongrass) Oil, Citral, Geraniol, Linalool
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm: 'Dream the night away' nighttime lotion | Experimental | The product should be applied once daily at night (30 minutes before bedtime). Participants should apply two teaspoons (one teaspoon of lotion covers approximately the size of the fingertip from tip to first knuckle) of lotion (3 mg of melatonin) and use it wherever they would usually use body lotion (paying particular attention to areas of tension in shoulders, neck, and temples, or on their legs and feet if they experience restless legs or muscle tightness).
Participants should do this for 20 nights. Receives: Other: Asutra's 'Dream the night away' nighttime lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in scores on the validated Sleep Quality Scale (SQS). [Timeline: Baseline to Week 3]
Consisting of 28 items, the SQS evaluates six domains of sleep quality: daytime symptoms, restoration after sleep, problems initiating. Using a four-point, Likert-type scale, respondents indicate how frequently they exhibit certain sleep behaviors (0 = "few," 1 = "some- times," 2 = "often," and 3 = "almost always").
Measured: 3 weeks
Changes in time asleep recorded by a wearable sleep tracker. [Timeline: Baseline to Week 3]
The total time asleep every night will be recorded using a wearable sleep tracker, the Fitbit Inspire 3.
Measured: 3 weeks
Changes in "sleep score" given by wearable sleep tracker. [Timeline: Baseline to Week 3]
The Fitbit Inspire 3 gives a nightly "sleep score". This is based on heart rate, the time spent awake or restless, and the sleep stages. The score is out of 100, with 100 being the best possible score.
Measured: 3 weeks
Secondary outcomes (1)
Participants' perceptions of the product's efficacy. [Timeline: Baseline to Week 3]
Participants' perception of the product's efficacy in improving sleep quality will be assessed via study-specific questionnaire. Participants will respond to Likert-scale questions (0-4 point scale) with 0=the least favourable score and 4=the most favourable score.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start7 Aug 2023
- Primary completion2 Oct 2023
- Study completion2 Oct 2023
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asutra
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146712
- Sponsor's protocol ID
- 20360
- Status last verified
- Nov 2023
- First submitted
- 18 Nov 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Group Study to Examine the Efficacy of a Melatonin Lotion With Magnesium to Improve Sleep Quality and Quantity
- ClinicalTrials.gov ID
- NCT06146712
- Acronym / sponsor ID
- 20360
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- AsutraIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 27 Nov 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.
This study will evaluate the efficacy of Asutra's 'Dream the night away' nighttime lotion with melatonin and magnesium on sleep health in terms of quantity, quality, ease of falling asleep or falling back asleep after waking in the night, and grogginess upon waking. The study will be conducted as a virtual single-group trial in which all 35 participants will use the test product. This study will last 3 weeks, and participants will use the product daily (each night 30 minutes before bedtime for 20 nights). Participants will use a sleep tracker to monitor their sleep for a week at Baseline (before commencing the trial) and nightly throughout the trial. Participants will complete study-specific questionnaires at Baseline, and after first use, 3 days, 1 week, 2 weeks, and 3 weeks, in which they will also record the results from their sleep tracker.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm: 'Dream the night away' nighttime lotion | Experimental | Other: Asutra's 'Dream the night away' nighttime lotionThe product should be applied once daily at night (30 minutes before bedtime). Participants should apply two teaspoons (one teaspoon of lotion covers approximately the size of the fingertip from tip to first knuckle) of lotion (3 mg of melatonin) and use it wherever they would usually use body lotion (paying particular attention to areas of tension in shoulders, neck, and temples, or on their legs and feet if they experience restless legs or muscle tightness). Participants should do this for 20 nights. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female aged 18-59.
- Must agree to not use any other sleep aids including prescriptions, supplements, or melatonin products during the study or 28 days prior to Baseline.
- Has favorable sleep conditions (a dark, quiet room to sleep in and is not woken up regularly throughout the night due to personal circumstances e.g. by a baby).
- Willing to maintain their standard sleep pattern and activity level for the duration of the study.
- Be generally healthy and not living with any uncontrolled chronic disease. Willing and able to supply and use their own sleep tracking device.
Key exclusion criteria (9 listed)
- Diagnosed with any chronic sleep condition including insomnia, narcolepsy, or sleep apnea.
- Has extremely sensitive/irritable skin or diagnosed skin conditions.
- Has poor sleep hygiene as a result of specific personal circumstances e.g. new mothers.
- Women who are pregnant, breastfeeding, or attempting to become pregnant.
- Anyone unwilling or unable to follow the study protocol.
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 |
|---|---|---|
| Asutra's 'Dream the night away' nighttime lotionProduct contains Water (Aqua), Magnesium Chloride, Dimethyl Sulfone (MSM), Prunus Amygdalus Dulcis (Sweet Almond) Oil, Butyrospermum Parkii (Shea Butter), Sodium Lactate, Cetearyl Alcohol, Glyceryl Stearate Citrate, Glycerin, Undecane, Cetyl Palmitate, Polyglyceryl-3 Diisostearate, Pentylene Glycol, Glyceryl Stearate, Magnesium Sulfate, Melatonin, Tridecane, Potassium Chloride, Sodium Chloride, Calcium Chloride, Tocopheryl Acetate, Xanthan Gum, Hydroxyacetophenone, Sodium Hydroxide, Cymbopogon Flexuosus (East-Indian Lemongrass) Oil, Citral, Geraniol, Linalool | Other | Intervention Arm: 'Dream the night away' nighttime lotion |
Primary outcome
Changes in scores on the validated Sleep Quality Scale (SQS). [Timeline: Baseline to Week 3]
Time frame: 3 weeks
Consisting of 28 items, the SQS evaluates six domains of sleep quality: daytime symptoms, restoration after sleep, problems initiating. Using a four-point, Likert-type scale, respondents indicate how frequently they exhibit certain sleep behaviors (0 = "few," 1 = "some- times," 2 = "often," and 3 = "almost always").
Changes in time asleep recorded by a wearable sleep tracker. [Timeline: Baseline to Week 3]
Time frame: 3 weeks
The total time asleep every night will be recorded using a wearable sleep tracker, the Fitbit Inspire 3.
Changes in "sleep score" given by wearable sleep tracker. [Timeline: Baseline to Week 3]
Time frame: 3 weeks
The Fitbit Inspire 3 gives a nightly "sleep score". This is based on heart rate, the time spent awake or restless, and the sleep stages. The score is out of 100, with 100 being the best possible score.
1 secondary outcome
Participants' perceptions of the product's efficacy. [Timeline: Baseline to Week 3]
Time frame: 3 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 27 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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 Asutra's 'Dream the night away' nighttime lotion in people with Sleep, run by Asutra 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 9 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 27 Nov 2023. 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?
Changes in scores on the validated Sleep Quality Scale (SQS). [Timeline: Baseline to Week 3] (time frame: 3 weeks). The study lists 3 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 27 Nov 2023.