Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07375095
Brief 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.
Detailed Description:
This study was a randomized, double-blind, placebo-controlled, parallel-group clinical trial conducted to evaluate the effects of a dietary sleep supplement on subjective sleep disturbance, sleep-related impairment, and related sleep parameters in perimenopausal and postmenopausal women with moderate sleep complaints.
Participants were enrolled remotely and randomized in a 1:1 ratio to receive either the investigational dietary supplement or a matching placebo. Randomization was performed using a blinded allocation scheme, and blinding was maintained for participants and all study personnel involved in participant management, data collection, and outcome assessment. Study products were physically and visuallyishable to preserve masking throughout the study.
Following electronic informed consent, participants completed a screening phase conducted via virtual visit, during which baseline sleep disturbance and medical history were assessed to confirm eligibility. 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 to 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 (Day 1) and self-administered the assigned study product once daily for 21 ± 3 days. The investigational product was administered orally approximately 60 minutes before bedtime, and participants randomized to placebo followed an identical dosing schedule.
Throughout the intervention period, participants completed daily electronic sleep diaries and periodic electronic questionnaires assessing changes in sleep disturbance, sleep-related impairment, overall sleep quality, and daytime functioning. Assessments were collected at baseline and at regular intervals during the dosing period, consistent with the protocol-defined schedule of activities. At the end-of-study visit, participants completed a product experience questionnaire evaluating usability and overall experience with the study product.
All study visits and assessments were conducted remotely. Safety and tolerability were monitored throughout the study through participant self-report and scheduled virtual check-ins. Adverse events were collected, assessed for severity and relatedness, and followed through resolution in accordance with protocol-defined safety monitoring procedures.
Each participant's total duration of participation was approximately four to five weeks, including screening, run-in, intervention, and end-of-study assessments. The study was designed to characterize the short-term effects, safety, and tolerability of a dietary sleep supplement in menopausal women experiencing moderate sleep disturbance under fully remote study conditions.
Study:
NCT07375095
Study Brief:
Protocol Section:
NCT07375095