Sleep DisturbancesNCT07839299
Bonafide Sleep Supplement for Menopausal Women With Impaired Sleep
A study testing S-Adenosyl Methionine (SAMe), Propyl Gallate, Gamma-Aminobutyric Acid (GABA), L-Theanine, and Magnesium Glycinate in people with Sleep Disturbances, run by Bonafide Health at 1 site in United States.
Trial summary
This open-label study evaluated whether a daily dietary sleep supplement could improve sleep and related daytime functioning in menopausal women aged 40 to 65 with impaired sleep. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbances
- What is being tested?
- S-Adenosyl Methionine (SAMe), Propyl Gallate, Gamma-Aminobutyric Acid (GABA), L-Theanine, and Magnesium Glycinate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2025to 23 Aug 2025
- 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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy women who are 40 to 65 years of age (inclusive).
- Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive).
- Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form (PROMIS SD SF) T-Score Cut Point ≥ 60 (equivalent to a raw score of 30).
- Women enrolled in this research study may be of perimenopausal, (12 or more months without a menstrual period) or post-menopausal status. Post-menopause defined as the last natural menstrual period (LNMP) completed at least 12 months prior to screening. Perimenopause defined as women who complained of irregular menstrual cycle in the past 12 months, with a forward or postponed cycle more than 7 days. At least 2 cycles were missing during the past 12 months or reported menopause for at least 60 days.
- In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.
- Agree to refrain from treatments listed in Section 12.4 in the defined timeframe.
- Has stable access to Wi-Fi and an iPhone or Android device.
- Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.
Who cannot join
- Individuals who are lactating, pregnant, or planning to become pregnant during the study.
- Perimenopausal women who are sexually active will be required to specify contraceptive method or be excluded.
- Currently incarcerated prisoners.
- Currently enrolled in a different clinical trial.
- Previous use of SAMe, PG, GABA, Theanine, and/or Magnesium (unless in a multivitamin) within 3 months prior to screening.
- Use of any treatment for sleep symptoms or other concomitant treatments listed in Section 12.4.
Show all 30Show fewer
- Taking blood thinners within the last 2 weeks. Further details may be found in Section 12.4.
- Have a known sensitivity, intolerability, or allergy to the study product or their excipients.
- Received a vaccine for COVID-19 in the two weeks prior to screening or during the study period, current COVID-19 infections, or currently have the post-COVID-19 condition as defined by World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually three months from the onset of COVID-19 with symptoms that last for at least two months and cannot be explained by an alternative diagnosis).
- Have a positive medical history of heart disease, renal disease, hepatic impairment, or active systemic infection (e.g., Lyme disease, TB, HIV).
- History of cancer (except localized skin cancer without metastases) within two (2) years prior to screening.
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study or influence the results or the potential subject's ability to participate in the study.
- History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (i.e., Crohn's disease, short bowel, acute or chronic pancreatitis, or pancreatic insufficiency).
- Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea).
- Major surgery in three months prior to screening or planned major surgery during the study.
- Currently diagnosed with depression by a doctor or physician.
- Have been or currently diagnosed with bipolar disorder by a doctor or physician.
- History of epilepsy or taking epileptic medications.
- Presence of sleep disorders that have been diagnosed by a doctor or physician.
- Currently using any sleep device (e.g., nebulizer machine, sleep apnea masks, continuous positive airway pressure (CPAP)) to improve sleep.
- Recent shift work, night work, or frequent travel to different time zones in the past month, which, in the opinion of the investigator, may adversely affect the participant's sleep quality.
- Consumption of more than 400 mg of caffeine per day.
- History of alcohol or substance abuse in the last 5 years.
- Report ≥ 14-night sweats per week.
- Report ≥ 20 hot flashes per week.
- Have animals that frequently cause sleep disturbances
- Have partners who regularly disturb their sleep
- Have young children or infants who frequently require caregiving responsibilities and disturb sleep
- Planned travel during the study period that, in the opinion of the investigator, may negatively influence the participant's sleep.
- Any other active or unstable medical conditions or use of medications/supplements/ therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant. Note: screened participants with infections would be eligible to participate four weeks after completing their treatment (wash-out period).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Bonafide Sleep Supplement on Sleep Parameters in Menopausal Women With Impaired Sleep: An Open-Label Experience Trial
This open-label study evaluated whether a daily dietary sleep supplement could improve sleep and related daytime functioning in menopausal women aged 40 to 65 with impaired sleep. Participants used the supplement for approximately 12 weeks, followed by a four-week period without the supplement to evaluate changes after discontinuation. Sleep, daytime functioning, product experience, safety, and tolerability were assessed throughout the study.
Read the detailed description
This was an open-label, single-group clinical trial conducted to evaluate the effects of a dietary sleep supplement on subjective sleep disturbance, sleep-related parameters, cognitive function, and well-being in perimenopausal and postmenopausal women with impaired sleep. All participants received the investigational dietary supplement.
Following electronic informed consent, participants completed a screening phase conducted via virtual visit, during which medical history, sleep disturbance, and other study eligibility criteria were assessed. Eligible participants then entered a run-in period of approximately seven days, during which they completed daily electronic sleep diaries to establish baseline sleep patterns and familiarize themselves with study procedures. No study product was consumed during the run-in period.
After completion of the run-in phase, participants initiated the intervention period on Day 1 and self-administered the study product once daily through approximately Day 85. The study product was administered orally as two tablets approximately 60 minutes before bedtime. Participants continued supplementation for approximately 12 weeks through the End of Intervention visit.
Throughout the intervention period, participants completed daily electronic sleep diaries and periodic electronic questionnaires assessing changes in sleep disturbance, sleep quality, cognitive function, daytime functioning, and overall well-being. Assessments were conducted at baseline and at regular intervals throughout the intervention period according to the protocol-defined schedule of activities. Participant experience with the study product was also assessed during the study.
Following completion of the intervention period, participants discontinued the study product and entered a washout period from approximately Day 86 through Day 113. Participants continued completing study assessments during this period to characterize changes in sleep and related outcomes after supplementation ended. A washout questionnaire was administered at the End of Study visit to evaluate participants' perceptions of changes in sleep, mood, cognitive function, and overall experience following discontinuation of the study product.
All study visits and assessments were conducted remotely through virtual or telephone visits. Safety and tolerability were monitored throughout the study through participant self-report, daily diary reporting, and scheduled safety check-ins. Adverse events were collected and monitored in accordance with protocol-defined safety procedures.
Each participant's total duration of participation was approximately 18 to 19 weeks, including screening, the run-in period, approximately 12 weeks of supplementation, the post-intervention washout period, and end-of-study assessments. The study was designed to characterize the effects, safety, tolerability, and participant experience associated with longer-term use of a dietary sleep supplement and to evaluate changes after discontinuation in menopausal women experiencing impaired sleep.
- Conditions
- Sleep Disturbances
- Being tested
- S-Adenosyl Methionine (SAMe), Propyl Gallate, Gamma-Aminobutyric Acid (GABA), L-Theanine, and Magnesium Glycinate
- Keywords
- Menopause, Perimenopause, Postmenopause, Sleep Disturbance, Sleep Quality, Sleep Onset Latency, Wake After Sleep Onset, Nighttime Awakenings, Daytime Functioning, Cognitive Function, Women's Health
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-Adenosyl Methionine (SAMe), Propyl Gallate, Gamma-Aminobutyric Acid (GABA), L-Theanine, and Magnesium GlycinateDietary supplement
Also called Bonafide Sleep
A daily dietary sleep supplement taken once per day for 85 days.
| Study group | Role | What they receive |
|---|---|---|
| Bonafide Sleep | Experimental | Participants received Bonafide Sleep orally as two tablets once daily approximately 60 minutes before bedtime from Day 1 through Day 85. After the intervention period, participants discontinued the study product and entered a washout period through Day 113. Receives: Dietary Supplement: S-Adenosyl Methionine (SAMe), Propyl Gallate, Gamma-Aminobutyric Acid (GABA), L-Theanine, and Magnesium Glycinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Short Form T-Score
Change from baseline in the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form (PROMIS SD SF) T-score. The PROMIS SD SF assesses self-reported perceptions of sleep, including difficulty getting to or staying asleep, sleep satisfaction, and overall sleep quality over the prior seven days.
Measured: Baseline (Day 1) through Day 113 (±3 days)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function Short Form T-Score
Change from baseline in the Patient-Reported Outcomes Measurement Information System Cognitive Function Short Form (PROMIS CF SF) T-score. The PROMIS CF SF assesses perceived cognitive abilities in everyday activities, including memory, attention, and mental clarity.
Measured: Baseline (Day 1) through Day 113 (±3 days)
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) score. The PSQI is a validated patient-reported instrument assessing sleep quality and disturbances over a one-month period, including sleep duration, sleep latency, habitual sleep efficiency, sleep disturbances, and overall subjective sleep quality.
Measured: Baseline (Day 1) through Day 113 (±3 days), assessed every 28 days
Secondary outcomes (14)
Change in Total Sleep Time (TST)
Change from run-in baseline in total nightly sleep duration, as recorded in daily morning sleep diaries.
Measured: Day -7 (run-in baseline) through Day 113 (±3 days)
Change in Sleep Disturbances
Change from run-in baseline in self-reported nighttime sleep disturbances, as recorded in daily morning sleep diaries.
Measured: Day -7 (run-in baseline) through Day 113 (±3 days)
Change in Wake After Sleep Onset (WASO)
Change from run-in baseline in wake after sleep onset, representing time spent awake after initially falling asleep, as recorded in daily morning sleep diaries.
Measured: Day -7 (run-in baseline) through Day 113 (±3 days)
Change in Sleep-Onset Latency (SOL)
Change from run-in baseline in sleep-onset latency, defined as the amount of time required to fall asleep after attempting to sleep, as recorded in daily morning sleep diaries.
Measured: Day -7 (run-in baseline) through Day 113 (±3 days)
Change in Daytime Sleepiness
Change from run-in baseline in participant-reported daytime sleepiness, as assessed through daily sleep diary responses.
Measured: Day -7 (run-in baseline) through Day 113 (±3 days)
Change in Sleep and Well-Being Complaints Questionnaire Responses
Change from baseline in participant-reported sleep and well-being complaints.
Measured: Baseline (Day 1) through Day 113 (±3 days), assessed every 28 days
Change in Sleep Quality as Measured by a Visual Analog Scale (VAS)
Change from baseline in self-reported sleep quality measured using a visual analog scale (VAS). The VAS is used to assess the participant's subjective perception of sleep quality and symptom severity over time.
Measured: Baseline (Day 1) through Day 113 (±3 days)
Change in Sleep Disturbances as Measured by a Visual Analog Scale (VAS)
Mean within-subject change from baseline in self-reported frequency of sleep disturbances measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates no sleep disturbances and peaceful sleep every night, while a score of 100 indicates constant sleep disturbances every night. Lower scores indicate fewer sleep disturbances.
Measured: Baseline through Week 16 (Day 113 ±3 days), assessed every 7 days
Change in Wakefulness After Sleep Onset (WASO) as Measured by a Visual Analog Scale (VAS)
Mean within-subject change from baseline in self-reported difficulty returning to sleep after awakening during the night, measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates no nighttime awakening, while a score of 100 indicates finding it very difficult or impossible to fall back asleep. Lower scores indicate better sleep maintenance.
Measured: Baseline through Week 16 (Day 113 ±3 days), assessed every 7 days
Change in Morning Ease as Measured by a Visual Analog Scale (VAS)
Mean within-subject change from baseline in self-reported difficulty leaving bed and beginning the day, measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates no difficulty, while a score of 100 indicates extreme difficulty that is nearly impossible to overcome. Lower scores indicate greater ease beginning the day.
Measured: Baseline through Week 16 (Day 113 ±3 days), assessed every 7 days
Change in Morning Grogginess as Measured by a Visual Analog Scale (VAS)
Mean within-subject change from baseline in self-reported morning grogginess measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates no grogginess and feeling fully alert upon waking, while a score of 100 indicates intense morning grogginess with marked drowsiness and lethargy. Lower scores indicate less morning grogginess.
Measured: Baseline through Week 16 (Day 113 ±3 days), assessed every 7 days
Change in Daytime Sleepiness as Measured by a Visual Analog Scale (VAS)
Mean within-subject change from baseline in self-reported daytime sleepiness measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates feeling alert and energetic without daytime sleepiness, while a score of 100 indicates daytime sleepiness dominated by an overpowering urge to sleep or nap. Lower scores indicate less daytime sleepiness.
Measured: Baseline through Week 16 (Day 113 ±3 days), assessed every 7 days
Participant Experience With the Study Product
Participant responses to the Product Experience Questionnaire assessing overall satisfaction with the study product, ease of use, perceived effects on sleep and daytime functioning, overall product experience, and willingness to recommend or continue using the product. Scored Likert items range from 1 (Strongly Disagree) to 4 (Strongly Agree), with higher scores indicating a more favorable product experience. Selected items include 0 = Not Applicable, which is not treated as a scored response. Additional items use Yes/No/Not Applicable or open-text responses. No composite total score is calculated; responses are summarized by individual item.
Measured: Week 12 (Day 85 ± 3 days) and Week 16 (Day 113 ± 3 days)
Participant-Reported Changes Following Study Product Discontinuation
Participant responses to the Washout Questionnaire assessing perceived changes following discontinuation of the study product, including sleep quality, daytime restfulness and energy, cognitive function, mood, overall satisfaction, perceived product benefit, and likelihood of recommending the product. The questionnaire uses item-specific ordered categorical response options, including 4-level responses (e.g., Very Dissatisfied to Very Satisfied; Strongly Disagree to Strongly Agree) and 5-level responses (e.g., Not Effective to Very Effective; Much Worse to Much Better; Definitely Not to Definitely Yes). More favorable response categories indicate a more favorable perceived outcome. No composite total score or single minimum/maximum questionnaire score is calculated; responses are summarized by individual item.
Measured: Week 16 (Day 113 ±3), following approximately 4 weeks of study product discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start3 Jan 2025
- Primary completion23 Aug 2025
- Study completion23 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbancesStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group, open-label study in which all participants received the investigational dietary sleep supplement during the intervention period, followed by a post-intervention washout period.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bonafide Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Trisha VanDusseldorp, PhD, Principal investigator, Bonafide Health, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839299
- Sponsor's protocol ID
- Pro00083186
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 24 Sep 2026
- 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 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bonafide Sleep Supplement on Sleep Parameters in Menopausal Women With Impaired Sleep: An Open-Label Experience Trial
- ClinicalTrials.gov ID
- NCT07839299
- Acronym / sponsor ID
- Pro00083186
- Conditions
- Sleep Disturbances
- Keywords
- Menopause, Perimenopause, Postmenopause, Sleep Disturbance, Sleep Quality, Sleep Onset Latency, Wake After Sleep Onset, Nighttime Awakenings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bonafide HealthIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 23 Aug 2025 (actual)
- Study completion
- 23 Aug 2025 (actual)
- First posted
- 24 Sep 2026 (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 open-label study evaluated whether a daily dietary sleep supplement could improve sleep and related daytime functioning in menopausal women aged 40 to 65 with impaired sleep. Participants used the supplement for approximately 12 weeks, followed by a four-week period without the supplement to evaluate changes after discontinuation. Sleep, daytime functioning, product experience, safety, and tolerability were assessed throughout the study.
Detailed description
This was an open-label, single-group clinical trial conducted to evaluate the effects of a dietary sleep supplement on subjective sleep disturbance, sleep-related parameters, cognitive function, and well-being in perimenopausal and postmenopausal women with impaired sleep. All participants received the investigational dietary supplement.
Following electronic informed consent, participants completed a screening phase conducted via virtual visit, during which medical history, sleep disturbance, and other study eligibility criteria were assessed. Eligible participants then entered a run-in period of approximately seven days, during which they completed daily electronic sleep diaries to establish baseline sleep patterns and familiarize themselves with study procedures. No study product was consumed during the run-in period.
After completion of the run-in phase, participants initiated the intervention period on Day 1 and self-administered the study product once daily through approximately Day 85. The study product was administered orally as two tablets approximately 60 minutes before bedtime. Participants continued supplementation for approximately 12 weeks through the End of Intervention visit.
Throughout the intervention period, participants completed daily electronic sleep diaries and periodic electronic questionnaires assessing changes in sleep disturbance, sleep quality, cognitive function, daytime functioning, and overall well-being. Assessments were conducted at baseline and at regular intervals throughout the intervention period according to the protocol-defined schedule of activities. Participant experience with the study product was also assessed during the study.
Following completion of the intervention period, participants discontinued the study product and entered a washout period from approximately Day 86 through Day 113. Participants continued completing study assessments during this period to characterize changes in sleep and related outcomes after supplementation ended. A washout questionnaire was administered at the End of Study visit to evaluate participants' perceptions of changes in sleep, mood, cognitive function, and overall experience following discontinuation of the study product.
All study visits and assessments were conducted remotely through virtual or telephone visits. Safety and tolerability were monitored throughout the study through participant self-report, daily diary reporting, and scheduled safety check-ins. Adverse events were collected and monitored in accordance with protocol-defined safety procedures.
Each participant's total duration of participation was approximately 18 to 19 weeks, including screening, the run-in period, approximately 12 weeks of supplementation, the post-intervention washout period, and end-of-study assessments. The study was designed to characterize the effects, safety, tolerability, and participant experience associated with longer-term use of a dietary sleep supplement and to evaluate changes after discontinuation in menopausal women experiencing impaired sleep.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group, open-label study in which all participants received the investigational dietary sleep supplement during the intervention period, followed by a post-intervention washout period.
| Arm | Type | Receives |
|---|---|---|
| Bonafide Sleep | Experimental | Dietary Supplement: S-Adenosyl Methionine (SAMe), Propyl Gallate, Gamma-Aminobutyric Acid (GABA), L-Theanine, and Magnesium GlycinateParticipants received Bonafide Sleep orally as two tablets once daily approximately 60 minutes before bedtime from Day 1 through Day 85. After the intervention period, participants discontinued the study product and entered a washout period through Day 113. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy women who are 40 to 65 years of age (inclusive).
- Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive).
- Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form (PROMIS SD SF) T-Score Cut Point ≥ 60 (equivalent to a raw score of 30).
- Women enrolled in this research study may be of perimenopausal, (12 or more months without a menstrual period) or post-menopausal status. Post-menopause defined as the last natural menstrual period (LNMP) completed at least 12 months prior to screening. Perimenopause defined as women who complained of irregular menstrual cycle in the past 12 months, with a forward or postponed cycle more than 7 days. At least 2 cycles were missing during the past 12 months or reported menopause for at least 60 days.
- In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.
Key exclusion criteria (30 listed)
- Individuals who are lactating, pregnant, or planning to become pregnant during the study.
- Perimenopausal women who are sexually active will be required to specify contraceptive method or be excluded.
- Currently incarcerated prisoners.
- Currently enrolled in a different clinical trial.
- Previous use of SAMe, PG, GABA, Theanine, and/or Magnesium (unless in a multivitamin) within 3 months prior to screening.
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 |
|---|---|---|
| S-Adenosyl Methionine (SAMe), Propyl Gallate, Gamma-Aminobutyric Acid (GABA), L-Theanine, and Magnesium GlycinateAlso: Bonafide SleepA daily dietary sleep supplement taken once per day for 85 days. | Dietary supplement | Bonafide Sleep |
Primary outcome
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Short Form T-Score
Time frame: Baseline (Day 1) through Day 113 (±3 days)
Change from baseline in the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form (PROMIS SD SF) T-score. The PROMIS SD SF assesses self-reported perceptions of sleep, including difficulty getting to or staying asleep, sleep satisfaction, and overall sleep quality over the prior seven days.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function Short Form T-Score
Time frame: Baseline (Day 1) through Day 113 (±3 days)
Change from baseline in the Patient-Reported Outcomes Measurement Information System Cognitive Function Short Form (PROMIS CF SF) T-score. The PROMIS CF SF assesses perceived cognitive abilities in everyday activities, including memory, attention, and mental clarity.
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Baseline (Day 1) through Day 113 (±3 days), assessed every 28 days
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) score. The PSQI is a validated patient-reported instrument assessing sleep quality and disturbances over a one-month period, including sleep duration, sleep latency, habitual sleep efficiency, sleep disturbances, and overall subjective sleep quality.
14 secondary outcomes
Change in Total Sleep Time (TST)
Time frame: Day -7 (run-in baseline) through Day 113 (±3 days)
Change in Sleep Disturbances
Time frame: Day -7 (run-in baseline) through Day 113 (±3 days)
Change in Wake After Sleep Onset (WASO)
Time frame: Day -7 (run-in baseline) through Day 113 (±3 days)
Change in Sleep-Onset Latency (SOL)
Time frame: Day -7 (run-in baseline) through Day 113 (±3 days)
Change in Daytime Sleepiness
Time frame: Day -7 (run-in baseline) through Day 113 (±3 days)
Change in Sleep and Well-Being Complaints Questionnaire Responses
Time frame: Baseline (Day 1) through Day 113 (±3 days), assessed every 28 days
Change in Sleep Quality as Measured by a Visual Analog Scale (VAS)
Time frame: Baseline (Day 1) through Day 113 (±3 days)
Change in Sleep Disturbances as Measured by a Visual Analog Scale (VAS)
Time frame: Baseline through Week 16 (Day 113 ±3 days), assessed every 7 days
Change in Wakefulness After Sleep Onset (WASO) as Measured by a Visual Analog Scale (VAS)
Time frame: Baseline through Week 16 (Day 113 ±3 days), assessed every 7 days
Change in Morning Ease as Measured by a Visual Analog Scale (VAS)
Time frame: Baseline through Week 16 (Day 113 ±3 days), assessed every 7 days
Change in Morning Grogginess as Measured by a Visual Analog Scale (VAS)
Time frame: Baseline through Week 16 (Day 113 ±3 days), assessed every 7 days
Change in Daytime Sleepiness as Measured by a Visual Analog Scale (VAS)
Time frame: Baseline through Week 16 (Day 113 ±3 days), assessed every 7 days
Participant Experience With the Study Product
Time frame: Week 12 (Day 85 ± 3 days) and Week 16 (Day 113 ± 3 days)
Participant-Reported Changes Following Study Product Discontinuation
Time frame: Week 16 (Day 113 ±3), following approximately 4 weeks of study product discontinuation
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 24 Sep 2026.
- 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.
Trisha VanDusseldorp, PhD principal investigator
Bonafide Health, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S-Adenosyl Methionine (SAMe), Propyl Gallate, Gamma-Aminobutyric Acid (GABA), L-Theanine, and Magnesium Glycinate in people with Sleep Disturbances, run by Bonafide Health 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 8 inclusion and 30 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 24 Sep 2026. 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?
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Short Form T-Score (time frame: Baseline (Day 1) through Day 113 (±3 days)). 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 24 Sep 2026.