NCT07069608

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

July 15, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

June 18, 2025

Last Update Submit

July 6, 2025

Conditions

Keywords

alcohol usewellness

Outcome Measures

Primary Outcomes (1)

  • Sleep Quality

    Sleep quality, as measured by wearables such as Fitbit, Garmin and Oura rings (time spent in sleep stages, wakeup events, sleep onset).

    6 weeks

Secondary Outcomes (2)

  • Alcohol Consumption Behavior

    6 weeks

  • Heart Rate Variability

    6 weeks

Interventions

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.

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a decentralized, 6 week observational cohort study conducted via the Alethios platform with approximately 100 participants.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2025

First Posted

July 16, 2025

Study Start

July 15, 2025

Primary Completion

August 30, 2025

Study Completion

October 31, 2025

Last Updated

July 16, 2025

Record last verified: 2025-07