Trial · NCT07880444
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Actigraphy-Derived Sleep Efficiency | Baseline, Week 4, Week 8 | Sleep efficiency will be assessed using 7-day wrist actigraphy and expressed as the percentage of time in bed spent asleep. Change from baseline will be assessed at each follow-up. |
| Primary | Change in Slow-Wave Sleep Duration | Baseline, Week 4, Week 8 | Slow-wave (N3) sleep will be assessed using one night of at-home electroencephalography with the Zmachine Insight device and expressed as minutes and percentage of total sleep time. Change from baseline will be assessed at each follow-up. |
| Primary | Change in Actigraphy-Derived Sleep Fragmentation Index | Baseline, Week 4, Week 8 | Sleep fragmentation will be assessed using 7-day wrist actigraphy. Higher values indicate greater sleep fragmentation. Change from baseline will be assessed at each follow-up. |
| Primary | Change in Skin hydration | Baseline, Week 4, Week 8 | Skin hydration will be measured using corneometry at the forehead, periorbital region, dorsal hand, and upper inner arm. Values will be expressed in arbitrary units, with higher values indicating greater hydration. Change from baseline will be assessed at each follow-up. |
| Secondary | Change in Pittsburgh Sleep Quality Index (PSQI) Global Score | Baseline, Week 4, Week 8 | Subjective sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Global scores range from 0 to 21, with higher scores indicating poorer sleep quality. Change from baseline will be assessed at each follow-up. |
| Secondary | Change in Insomnia Severity Index (ISI) Score | Baseline, Week 4, Week 8 | Insomnia severity will be assessed using the Insomnia Severity Index (ISI). Total scores range from 0 to 28, with higher scores indicating greater insomnia severity. Change from baseline will be assessed at each follow-up. |
| Secondary | Change in Epworth Sleepiness Scale (ESS) Score | Baseline, Week 4, Week 8 | Daytime sleepiness will be assessed using the Epworth Sleepiness Scale (ESS). Total scores range from 0 to 24, with higher scores indicating greater daytime sleepiness. Change from baseline will be assessed at each follow-up. |
| Secondary | Change in Ru-SATED Multidimensional Sleep Health Score | Baseline, Week 4, Week 8 | Multidimensional sleep health will be assessed using the RU-SATED Sleep Health Scale. Total scores range from 0 to 12, with higher scores indicating better sleep health. Change from baseline will be assessed at each follow-up. |
| Secondary | Change in Skin elasticity | Baseline, Week 4, Week 8 | Skin elasticity will be measured using an ElastiMeter® (Delfin Technologies Ltd., Kuopio, Finland). Instant Skin Elasticity (ISE) will be reported in newtons per meter (N/m), with higher values indicating greater skin elasticity. Change from baseline will be assessed at each follow-up. |
| Secondary | Change in Transepidermal water loss (TEWL) | Baseline, Week 4, Week 8 | Skin barrier function will be assessed by transepidermal water loss using a VapoMeter® and reported in g·m-²·h-¹. Change from baseline will be assessed at each follow-up. |
| Secondary | Change in Skin Sebum Content | Baseline, Week 4, Week 8 | Skin sebum content will be measured using a Sebumeter® and reported in micrograms per square centimeter (µg/cm²), with higher values indicating greater skin surface sebum content. Change from baseline will be assessed at each follow-up. |
| Secondary | Change in Skin Pigmentation | Baseline, Week 4, Week 8 | Skin pigmentation will be assessed using Antera 3D® imaging (Miravex Ltd., Ireland). Average pigmentation concentration will be reported in arbitrary units (AU), with higher values indicating greater skin pigmentation. Change from baseline will be assessed at each follow-up. |
| Secondary | Change in Wrinkle Severity | Baseline, Week 4, Week 8 | Average wrinkle depth will be assessed using Antera 3D® imaging (Miravex Ltd., Ireland) and reported in millimeters (mm), with higher values indicating deeper wrinkles. Change from baseline will be assessed at each follow-up. |
| Secondary | Change in Collagen integrity | Baseline, Week 4, Week 8 | Dermal collagen will be assessed noninvasively using the Dermo® collagen measurement device (Mondray Technologies, Greenwich, CT). The device uses spatially resolved spectroscopy to derive a collagen measurement from the optical scattering properties of the dermis. Collagen values are reported on a device-derived scale ranging from 10 to 99, with higher values indicating greater dermal collagen content. Change from baseline will be assessed at each follow-up. |
| Secondary | Change in Menopausal Skin Quality of Life (MSkinQOL) Scores | Baseline, Week 4, Week 8 | The 28-item questionnaire assesses three dimensions: health status, self-esteem, and social effects of skin appearance. Items are rated on a 5-point scale from 0 (never) to 4 (always), with higher scores indicating greater symptom frequency or greater negative impact on quality of life. Change from baseline in MSkinQOL dimension scores will be assessed at each follow-up. |
| Secondary | Change in Flow-mediated dilation (FMD) | Baseline, Week 4, Week 8 | Brachial artery endothelial function will be assessed using ultrasound-based flow-mediated dilation following 5 minutes of forearm cuff occlusion. FMD will be expressed as the absolute and percentage change in brachial artery diameter from pre-occlusion baseline to the post-occlusion peak diameter. Change from baseline in FMD will be assessed at each follow-up. |
| Secondary | Change in Carotid-Femoral Pulse Wave Velocity (PWV) | Baseline, Week 4, Week 8 | Arterial stiffness will be assessed using carotid-femoral pulse wave velocity. Pulse transit time will be determined from carotid and femoral arterial waveforms, and pulse wave velocity will be calculated as distance traveled divided by transit time and expressed in meters per second (m/s). Higher values indicate greater arterial stiffness. Change from baseline will be assessed at each follow-up |
| Secondary | Height | Baseline | Standing height will be measured in centimeters (cm) using a calibrated stadiometer |
| Secondary | Change in Body Weight | Baseline, Week 4, Week 8 | Body weight will be measured in kilograms (kg) using a calibrated digital scale. Change from baseline will be assessed at each follow-up. |
| Secondary | Change in Body Mass Index (BMI) | Baseline, Week 4, Week 8 | BMI will be calculated as weight (kg) divided by height squared (m²). Change from baseline will be assessed at each follow-up. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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