Trial · NCT07903051
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Sleep Time (TST) on the Night Before Surgery | Night before surgery | Total sleep time measured by a wrist-worn sleep monitoring device (Huawei smart band) during the night before brain tumor surgery. TST is defined as the total duration of sleep from sleep onset to final awakening, reported in minutes. |
| Secondary | Subjective sleep quality | Preoperative day 1, Postoperative days 1-3 (assessed at 8:00-10:00 AM) | Richards-Campbell Sleep Questionnaire (RCSQ) score. The RCSQ is a 5-item visual analog scale assessing sleep depth, sleep onset latency, awakenings, time spent awake, and overall sleep quality. Each item scored 0-100, total score is the mean of 5 items, range 0-100, higher scores indicate better sleep. |
| Secondary | Objective sleep quality | Postoperative night 0 (20:00 to 08:00 next day) and Postoperative night 2 (20:00 to 08:00 next day) | Total sleep time measured by a wrist-worn sleep monitoring device (Huawei smart band) during the night of postoperative day 0. Reported in minutes. |
| Secondary | Time to Extubation | Immediately after surgery | Time from the end of surgery to extubation, defined as removal of the endotracheal tube. Reported in minutes. |
| Secondary | Time to Awakening | Immediately after surgery | Time from the end of anesthesia to the first response to verbal command. Reported in minutes. |
| Secondary | Perioperative Anxiety Visual Analog Scale (VAS-A) Score | Perioperative [Upon entry to the operating room (before induction of anesthesia), and 1 hour after surgery] | Anxiety Visual Analog Scale (VAS-A) score. The VAS-A is a 100-mm horizontal line anchored at 0 (no anxiety) and 100 (worst possible anxiety). The participant marks a point on the line corresponding to their anxiety level. Higher scores indicate greater anxiety. VAS-A score assessed upon entry to the operating room (before induction of anesthesia) and 1 hour after surgery. |
| Secondary | Postoperative Hospital Anxiety and Depression Scale (HADS) Score | Postoperative day 1 and 3 (assessed at 8:00-10:00 AM) | The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-rated questionnaire comprising two 7-item subscales: anxiety (HADS-A) and depression (HADS-D). Each item is scored from 0 to 3. Each subscale score ranges from 0 to 21, with higher scores indicating greater symptom severity. |
| Secondary | Postoperative pain measured by Pain Numeric Rating Scale (NRS) score | 1 hour after surgery, 24 hours, 48 hours and 72 hours after surgery. | Pain Numeric Rating Scale (NRS) score. The NRS is an 11-point scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity. |
| Secondary | Postoperative Quality of Recovery-15 (QoR-15) | Postoperative day 1 | Quality of Recovery-15 (QoR-15) score. The QoR-15 is a 15-item questionnaire assessing postoperative recovery across physical comfort, emotional state, and physical independence. Each item scored 0-10, total range 0-150, higher scores indicate better recovery quality. |
| Secondary | Incidence of Postoperative Delirium | Within 3 days after surgery (assessed twice daily) | Postoperative delirium will be assessed using the 3-Dimensional Confusion Assessment Method (3D-CAM). The 3D-CAM is a structured diagnostic interview that determines the presence or absence of CAM-defined delirium. Delirium incidence is the number of participants with at least one positive 3D-CAM assessment. |
| Secondary | Pittsburgh Sleep Quality Index (PSQI) Score at 1 Month After Surgery | 1 month after surgery | Pittsburgh Sleep Quality Index (PSQI) score. The PSQI is a 19-item self-rated questionnaire assessing sleep quality over the past month. Seven component scores are summed to yield a global score ranging from 0 to 21. Higher scores indicate worse sleep quality. |
| Secondary | Karnofsky Performance Status (KPS) Score at 1 Month After Surgery | 1 month after surgery | Karnofsky Performance Status (KPS) score. The KPS is a clinician-rated scale ranging from 0 to 100, with scores assigned in 10-point increments. Higher scores indicate better functional status and greater ability to carry out daily activities independently. Assessed by a clinician at 1 month after surgery. |
| Other | Total Sleep Time (TST) as Measured by Polysomnography (PSG) | Preoperative Day 1 (the night before surgery) | Total sleep time, defined as the total duration of sleep from sleep onset to final awakening, measured by 8-channel polysomnography. Reported in minutes. |
| Other | Sleep Efficiency (SE) as Measured by Polysomnography (PSG) | Preoperative Day 1 (the night before surgery) | Sleep efficiency, defined as total sleep time divided by total time in bed, expressed as a percentage. Measured by 8-channel polysomnography. |
| Other | Sleep Onset Latency (SOL) as Measured by Polysomnography (PSG) | Preoperative Day 1 (the night before surgery) | Sleep onset latency, defined as the time from lights off to the first epoch of any sleep stage, measured by 8-channel polysomnography. Reported in minutes. |
| Other | Percentage of Rapid Eye Movement (REM) Sleep as Measured by Polysomnography (PSG) | Preoperative Day 1 (the night before surgery) | Percentage of total sleep time spent in REM sleep, measured by 8-channel polysomnography. Reported as a percentage. |
| Other | Percentage of Non-REM Stage N3 Sleep as Measured by Polysomnography (PSG) | Preoperative Day 1 (the night before surgery) | Percentage of total sleep time spent in N3 (slow-wave) sleep, measured by 8-channel polysomnography. Reported as a percentage. |
| Other | Wake After Sleep Onset (WASO) as Measured by Polysomnography (PSG) | Preoperative Day 1 (the night before surgery) | Wake after sleep onset, defined as the total time spent awake after initial sleep onset, measured by 8-channel polysomnography. Reported in minutes. |
| Other | Plasma Orexin-A Level | Preoperative day 1, day of surgery (before anesthesia induction), postoperative day 1 | Fasting plasma orexin-A concentration measured by enzyme-linked immunosorbent assay (ELISA). Reported in pg/mL. |
| Other | Number of Participants with Treatment-Emergent Adverse Events | Perioperative period (from study drug administration on the night before surgery through hospital discharge, approximately 5 days) | Number of participants experiencing any adverse event during the perioperative period, including but not limited to falls, nocturnal hypoxemia, abnormal dreams, somnolence, constipation, arthralgia, and headache. |
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.
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