Trial · NCT07894562
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI) | Baseline (week 0) and week 8 | Global PSQI score (sum of 7 components, each 0-3). Range 0-21; higher scores indicate worse sleep quality. Change from baseline to week 8 compared between groups. |
| Primary | Change in insomnia severity measured by the Insomnia Severity Index (ISI) | Baseline (week 0) and week 8 | ISI total score (7 items, each 0-4). Range 0-28; higher scores indicate greater insomnia severity (0-7 no clinically significant insomnia, 8-14 subthreshold, 15-21 moderate, 22-28 severe). |
| Primary | Change in health-related quality of life measured by the EQ-5D-5L index | Baseline (week 0) and week 8 | EQ-5D-5L descriptive system (mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each rated on 5 levels), converted into a utility index using the Spanish value set. Index values up to 1 (full health); higher values indicate better health-related quality of life. |
| Primary | Change in self-rated health measured by the EQ visual analogue scale (EQ VAS) | Baseline (week 0) and week 8 | EQ VAS from the EQ-5D-5L questionnaire. Range 0 (worst imaginable health) to 100 (best imaginable health); higher scores indicate better self-rated health. |
| Secondary | Change in total sleep duration | Baseline (week 0) and week 8 | Self-reported total hours of actual sleep per night during the past month, obtained from the PSQI (hours). |
| Secondary | Change in sleep onset latency | Baseline (week 0) and week 8 | Self-reported time (minutes) needed to fall asleep each night during the past month, obtained from the PSQI. |
| Secondary | Change in habitual sleep efficiency | Baseline (week 0) and week 8 | Sleep efficiency (%) calculated as hours slept divided by hours spent in bed x 100, obtained from the PSQI. Higher values indicate better sleep efficiency. |
| Secondary | Change in body mass index (BMI) | Baseline (week 0) and week 8 | BMI (kg/m\^2) calculated from body weight (kg), measured fasting with light clothing on a calibrated scale, and height (cm), measured with a fixed stadiometer. |
| Secondary | Change in waist circumference | Baseline (week 0) and week 8 | Waist circumference (cm) measured at the midpoint between the lower rib margin and the iliac crest, standing, at the end of a normal expiration, with an inextensible tape. |
| Secondary | Change in systolic blood pressure | Baseline (week 0) and week 8 | Systolic blood pressure (mmHg) measured seated after at least 5 minutes of rest with a validated device; three readings 1 minute apart, using the mean of the last two. |
| Secondary | Change in diastolic blood pressure | Baseline (week 0) and week 8 | Diastolic blood pressure (mmHg) measured seated after at least 5 minutes of rest with a validated device; three readings 1 minute apart, using the mean of the last two. |
| Secondary | Change in fasting plasma glucose | Baseline (week 0), week 4 and week 8 | Fasting glucose (mg/dL) determined by enzymatic spectrophotometric methods in venous blood obtained after at least 8 hours of fasting. |
| Secondary | Change in fasting insulin | Baseline (week 0), week 4 and week 8 | Fasting serum insulin (μIU/mL) in venous blood obtained after at least 8 hours of fasting. |
| Secondary | Change in high-sensitivity C-reactive protein (hs-CRP) | Baseline (week 0), week 4 and week 8 | Serum hs-CRP (mg/L) quantified by high-sensitivity immunoassay (turbidimetry or chemiluminescence) in fasting venous blood. |
| Secondary | Change in serum interleukin-6 (IL-6) | Baseline (week 0), week 4 and week 8 | Serum IL-6 (pg/mL) quantified by ELISA or multiplex immunoassay in fasting venous blood. |
| Secondary | Change in serum tumor necrosis factor alpha (TNF-α) | Baseline (week 0), week 4 and week 8 | Serum TNF-α (pg/mL) quantified by ELISA or multiplex immunoassay in fasting venous blood. |
| Secondary | Change in evening serum cortisol | Baseline (week 0), week 4 and week 8 | Serum cortisol (μg/dL) in blood drawn in the evening (16:00-18:00 h), determined by chemiluminescence immunoassay or LC-MS/MS. |
| Secondary | Change in lipid peroxidation measured by malondialdehyde (MDA) | Baseline (week 0), week 4 and week 8 | Plasma/serum malondialdehyde concentration as a marker of oxidative lipid damage, where technically feasible. |
| Secondary | Change in total antioxidant capacity | Baseline (week 0), week 4 and week 8 | Total antioxidant capacity of plasma/serum, where technically feasible. |
| Secondary | Change in body weight | Baseline (week 0) and week 8 | Body weight (kg) measured fasting, barefoot and in light clothing on a calibrated scale (precision 100 g). |
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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GET https://conductscience.org/api/trials/v1/NCT07894562/registered