SleepNCT07069608
Cheers Health Restore Study
An observational study of Sleep and Alcohol Aftereffects, run by Cheers Health.
Trial summary
This observational cohort study, sponsored by Cheers Health and conducted by Principal Investigator Dr. Nirav Shah, aims to evaluate the potential role of Cheers Restore in supporting sleep quality, physiological recovery, and next-day well-being following alcohol consumption in healthy adults. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep, Alcohol Aftereffects, Recovery
- What is being tested?
- Cheers Restore
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2025to 31 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is a decentralized, 6 week observational cohort study conducted via the Alethios platform with approximately 100 participants.
Who may be able to join
- Adults aged 21 years or older
- Regular alcohol consumers (defined as ≥1 drinking night per week)
- Ownership of and willingness to use a wearable device compatible with the Alethios platform (e.g., Fitbit, Apple Watch, Oura)
- Ability and willingness to log alcohol consumption, Cheers Restore usage, and complete daily and weekly surveys via smartphone or web
- Willingness to use Cheers Restore during the study period when consuming alcohol
- English-speaking, capable of understanding informed consent
Who cannot join
- AUDIT-C score above gender-specific thresholds for hazardous drinking (≥4 for men, ≥3 for women)
- History of alcohol use disorder or prior treatment for substance misuse
- Routine binge drinking (≥5 drinks/occasion for men, ≥4 for women)
- Use of confounding substances:
- THC (any form)
- Recreational drugs
Show all 11Show fewer
- Prescription stimulants, sedatives, or sleep aids
- Diagnosed sleep or psychiatric conditions known to impair sleep quality (e.g., insomnia, obstructive sleep apnea, restless legs syndrome, narcolepsy, major depressive disorder, post-traumatic stress disorder, bipolar disorder, schizophrenia, attention deficit/hyperactivity disorder)
- Pregnancy or breastfeeding
- Anticipated travel or scheduling conflicts disrupting normal sleep/alcohol routines
- Inability to comply with platform-based data collection requirements
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cheers Health Restore Observational Study
This observational cohort study, sponsored by Cheers Health and conducted by Principal Investigator Dr. Nirav Shah, aims to evaluate the potential role of Cheers Restore in supporting sleep quality, physiological recovery, and next-day well-being following alcohol consumption in healthy adults. Over a 6 week period, the study will utilize wearable devices and self-reported outcomes captured via the Alethios platform to assess real-world responses to use of Cheers Restore. Outcomes will be compared across three behavioral conditions: (1) alcohol consumption followed by Cheers Restore use, (2) alcohol-only nights without use of Cheers Restore, and (3) non-drinking nights.
Read the detailed description
Alcohol consumption is known to reduce REM sleep, impair heart rate variability (HRV), and increase next-day fatigue, irritability, and cognitive disruption. Moderate alcohol intake can disrupt circadian rhythm and impair autonomic recovery. Prior research has shown dietary supplements containing amino acids, antioxidants, and electrolytes may support recovery, but few studies have assessed real-world behavioral patterns using digital health technology. Observational data from wearable devices and participant-reported outcomes can offer scalable, ecologically valid insights into how lifestyle products may mitigate alcohol-induced disruption.
Cheers Restore contains a formulation of antioxidants, electrolytes, and plant-based compounds designed to support physiological resilience and sleep recovery after alcohol consumption. This study is structured to evaluate Cheers Restore in a real-world setting without introducing investigational or therapeutic claims. By capturing participant-driven usage patterns and outcomes, the study enables ecological validation and supports responsible product communication aligned with DSHEA and FTC guidelines.
- Conditions
- Sleep, Alcohol Aftereffects, Recovery
- Being tested
- Cheers Restore
- Keywords
- alcohol use, wellness
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cheers RestoreDietary supplement
Cheers Restore contains a formulation of antioxidants, electrolytes, and plant-based compounds designed to support physiological resilience and sleep recovery after alcohol consumption. This study is structured to evaluate Cheers Restore in a real-world setting without introducing investigational or therapeutic claims.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
Sleep quality, as measured by wearables such as Fitbit, Garmin and Oura rings (time spent in sleep stages, wakeup events, sleep onset).
Measured: 6 weeks
Secondary outcomes (2)
Alcohol Consumption Behavior
Alcohol consumption behavior, including quantity (number of standard drinks), frequency of alcohol consumption, and timing as measured by weekly surveys.
Measured: 6 weeks
Heart Rate Variability
Heart Rate Variability during sleep as measured by wearable devices e.g. Garmin, Oura, Fitbit.
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 posted16 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cheers Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alethios, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069608
- Sponsor's protocol ID
- 1002
- Status last verified
- Jul 2025
- First submitted
- 18 Jun 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Song S, Wang Y, Atwood L, Shah NR, Jarral RA. Decentralized Assessment of a Dihydromyricetin- and L-Cysteine-Based Multi-Ingredient Dietary Supplement on Post-Alcohol Recovery: An Observational Cohort Study. Nutrients. 2026 Jul 24;18(15):2424. doi: 10.3390/nu18152424.
PubMed 42588049
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cheers Health Restore Observational Study
- ClinicalTrials.gov ID
- NCT07069608
- Acronym / sponsor ID
- 1002
- Conditions
- Sleep, Alcohol Aftereffects, Recovery
- Keywords
- alcohol use, wellness
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cheers HealthIndustry (pharma, biotech, devices)
- Collaborators
- Alethios, Inc.
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 16 Jul 2025 (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 observational cohort study, sponsored by Cheers Health and conducted by Principal Investigator Dr. Nirav Shah, aims to evaluate the potential role of Cheers Restore in supporting sleep quality, physiological recovery, and next-day well-being following alcohol consumption in healthy adults. Over a 6 week period, the study will utilize wearable devices and self-reported outcomes captured via the Alethios platform to assess real-world responses to use of Cheers Restore. Outcomes will be compared across three behavioral conditions: (1) alcohol consumption followed by Cheers Restore use, (2) alcohol-only nights without use of Cheers Restore, and (3) non-drinking nights.
Detailed description
Alcohol consumption is known to reduce REM sleep, impair heart rate variability (HRV), and increase next-day fatigue, irritability, and cognitive disruption. Moderate alcohol intake can disrupt circadian rhythm and impair autonomic recovery. Prior research has shown dietary supplements containing amino acids, antioxidants, and electrolytes may support recovery, but few studies have assessed real-world behavioral patterns using digital health technology. Observational data from wearable devices and participant-reported outcomes can offer scalable, ecologically valid insights into how lifestyle products may mitigate alcohol-induced disruption.
Cheers Restore contains a formulation of antioxidants, electrolytes, and plant-based compounds designed to support physiological resilience and sleep recovery after alcohol consumption. This study is structured to evaluate Cheers Restore in a real-world setting without introducing investigational or therapeutic claims. By capturing participant-driven usage patterns and outcomes, the study enables ecological validation and supports responsible product communication aligned with DSHEA and FTC guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is a decentralized, 6 week observational cohort study conducted via the Alethios platform with approximately 100 participants.
Key inclusion criteria (6 listed)
- Adults aged 21 years or older
- Regular alcohol consumers (defined as ≥1 drinking night per week)
- Ownership of and willingness to use a wearable device compatible with the Alethios platform (e.g., Fitbit, Apple Watch, Oura)
- Ability and willingness to log alcohol consumption, Cheers Restore usage, and complete daily and weekly surveys via smartphone or web
- Willingness to use Cheers Restore during the study period when consuming alcohol
Key exclusion criteria (11 listed)
- AUDIT-C score above gender-specific thresholds for hazardous drinking (≥4 for men, ≥3 for women)
- History of alcohol use disorder or prior treatment for substance misuse
- Routine binge drinking (≥5 drinks/occasion for men, ≥4 for women)
- Use of confounding substances:
- THC (any form)
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 |
|---|---|---|
| Cheers RestoreCheers Restore contains a formulation of antioxidants, electrolytes, and plant-based compounds designed to support physiological resilience and sleep recovery after alcohol consumption. This study is structured to evaluate Cheers Restore in a real-world setting without introducing investigational or therapeutic claims. | Dietary supplement | – |
Primary outcome
Sleep Quality
Time frame: 6 weeks
Sleep quality, as measured by wearables such as Fitbit, Garmin and Oura rings (time spent in sleep stages, wakeup events, sleep onset).
2 secondary outcomes
Alcohol Consumption Behavior
Time frame: 6 weeks
Heart Rate Variability
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Derived from this study: PubMed 42588049Song S, Wang Y, Atwood L, Shah NR, Jarral RA. Decentralized Assessment of a Dihydromyricetin- and L-Cysteine-Based Multi-Ingredient Dietary Supplement on Post-Alcohol Recovery: An Observational Cohort Study. Nutrients. 2026 Jul 24;18(15):2424. doi: 10.3390/nu18152424.
- Cheers Restore Observational Study Landing Page and Eligibility QuestionnaireLink provided by the sponsor.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep and Alcohol Aftereffects, run by Cheers Health.
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 6 inclusion and 11 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: opening soon, as of the sponsor's last update on 16 Jul 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nirav Shah, MD ((650) 206-8006, nirav@investigator.alethios.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07069608, which also lists 1 linked publication.
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 16 Jul 2025.