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NCT07375095 · ClinicalTrials.gov registry record · NA
A Study of a Sleep Supplement to Improve Sleep in Women Going Through Menopause
A NA study of Sleep Disturbance, sponsored by Bonafide Health.
- Completed
- Registry status
- NA
- Development phase
- 128
- Enrollment target
- 1
- Study location
NCT07375095: Completed NA study of Sleep Disturbance, sponsored by Bonafide Health.
NCT07375095 is a NA study of Sleep Disturbance that has completed, run by Bonafide Health. The registered enrollment target is 128 participants, below the 176-participant average among 56 other Sleep Disturbance trials with a reported enrollment target (27% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07375095, a NA study of Sleep Disturbance, has completed, sponsored by Bonafide Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 128 participants
- Enrollment target
- 1
- Study location
Study Summary
This study evaluated whether a daily dietary sleep supplement could improve sleep in women aged 40 to 65 who experience moderate sleep disturbances during menopause. Participants were randomly assigned to take either the supplement or a placebo for about three weeks. All study visits were conducted virtually. Sleep was assessed through daily diaries and weekly questionnaires measuring sleep quality, nighttime awakenings, daytime alertness, and mood. The study's goal was to compare changes between the supplement and placebo groups and to assess safety and tolerability during the study period.
Primary Outcome
Change from baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Short Form 8b T-score, a validated patient-reported outcome measure assessing perceived sleep quality, difficulty falling or staying asleep, and overall sleep satisfaction over the prior 7 days. The PROMIS Sleep Disturbance Short Form 8b yields raw scores ranging from 8 to 40, which are converted to standardized T-scores ranging from 28.9 to 76.5. Higher T-scores indicate greater slee
Conditions Studied
Interventions
- DRUG Placebo
- DIETARY_SUPPLEMENT Sleep Supplement
Study Locations (1)
New York
- Bonafide Health, LLC - Harrison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2023-10-10 |
| Est. Completion | 2024-04-07 |
| Phase | NA |
What the finished NCT07375095 record still lists
NCT07375095 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 176-participant average among 56 other Sleep Disturbance trials with a reported enrollment target (27% lower).
The record links to 1 condition, with Sleep Disturbance appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07375095 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT07375095 about?
NCT07375095 is a clinical study titled "A Study of a Sleep Supplement to Improve Sleep in Women Going Through Menopause". This study evaluated whether a daily dietary sleep supplement could improve sleep in women aged 40 to 65 who experience moderate sleep disturbances during menopause. Participants were randomly assigned to take either the supplement or a placebo for about three weeks. All study visits were conducted ...
What is the current status of trial NCT07375095?
This trial is currently completed. It is a NA study. The enrollment target is 128 participants. The study started on 2023-10-10. Estimated completion is 2024-04-07.
What conditions does trial NCT07375095 study?
This clinical trial studies the following conditions: Sleep Disturbance.
What interventions are being tested in trial NCT07375095?
The interventions under investigation include: Placebo (DRUG), Sleep Supplement (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT07375095?
This trial is sponsored by Bonafide Health, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07375095 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07375095's enrollment target sits among peer trials
128 18th of 56 higher than 39 of 56 other Sleep Disturbance trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sleep Disturbance trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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