Trial · NCT07903896
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PANAS-10 | periprocedurally* measures collected during lab weekends (i.e. periprocedurally) ONLY - marked with " * " | EMA Mood 10 items 5-pt Likert Score: 10-50 |
| Primary | POMS-8 [depression subscale of POMS-60] | periprocedurally* | EMA Depressed Mood 8 items 5-pt Likert Score: 0-32 |
| Primary | PHQ-9 | baseline, pre-intervention, periprocedurally | EMA Depressed Mood 9 items 4-pt Likert Score: 0-27 |
| Primary | GAD-7 | baseline, pre-intervention, periprocedurally | EMA Anxious Mood 7 items 4-pt Likert Score: 0-21 |
| Primary | Qualitative Experience | immediately after intervention* | In-person interview |
| Secondary | Sleep Self Assessment | pre-intervention, periprocedurally | Audio-diary |
| Secondary | Sleep Monitoring | pre-intervention, periprocedurally | i) Sleep Stages (times, duration) - est. from Heart Rate (BPM) + Movement. Stages = Light, Deep, REM ii) Time Asleep \& Time in Bed iii) Time Awake \& Restlessness |
| Secondary | 18-channel attended polysomnography (PSG) | periprocedurally* | i) EEG (32-channel, 10-20 system) Sleep stage distribution: N1, N2, N3, REM (% and minutes per stage) Total Sleep Time (TST) Sleep Onset Latency (SOL) REM Latency Wake After Sleep Onset (WASO) Sleep Efficiency (TST / Time in Bed) Number of awakenings Arousal Index (EEG-defined arousals/hour, AASM criteria) Spontaneous (non-respiratory, non-limb) arousal count ii) EOG REM density iii) Submental EMG Atonia confirmation for REM staging Chin EMG tone, used jointly with EEG/EOG for arousal scoring iv) Bilateral anterior tibialis EMG Periodic Limb Movement Index (PLMI; events/hour) PLM Arousal Index (PLM events assoc. EEG arousal) v) ECG Heart Rate \& Variability across sleep stages vi) Nasal pressure + oronasal thermal airflow AHI vii) Thoracic + abdominal respiratory effort belt Obstructive vs. central, RERA → RDI viii) Pulse oximetry SpO2 nadir ODI, ≥3% or ≥4% threshold %TST \< 90% ix) Snore sensor * TST snoring x) Body position sensor T/pos (supine, lateral, prone) Pos-dependent AHI |
| Secondary | Actigraphy | pre-intervention, periprocedurally | i) Steps/day ii) Distance/day iii) Heart rate (BPM) |
| Secondary | Flanker Task | pre-intervention, periprocedurally | EMA i) Reaction Time (RT) Mean/median RT (ms) / trial type x Congruent v. Incongruent trials Flanker Effect (or interference effect) = RT(incongruent) - RT(congruent) ii) Accuracy % correct x Congruent v. Incongruent Accuracy Interference Effect = accuracy(congruent) - accuracy(incongruent) |
| Secondary | 2-Back Task | pre-intervention, periprocedurally | EMA i) Hit Rate * correctly identified targets ii) Miss Rate * targets not identified iii) False Alarm Rate * non-target trials incorrectly identified as targets iv) Correct Rejection Rate * correctly identified non-targets v) d' (d-prime) z(hit rate) - z(false alarm rate) vi) c (criterion) or β (beta) response bias |
| Secondary | Body Temperature | pre-intervention, periprocedurally | i) Skin-surface (C/F) ii) Core (C/F) iii) Peripheral (C/F) |
| Other | Waking EEG [128-lead saline cap] | periprocedurally* | i) Beta-to-Theta Power Ratio - calculated from frontal scalp electrodes Beta = 13-30 Hz Theta = 4-7 Hz ii) Source-reconstructed lagged phase synchronization between Default Mode Network and Salience Network ROIs - computed per frequency band from 128-channel resting-state hdEEG (eyes-open and eyes-closed analyzed separately). iii) P300 (P3b) Event Related Potential Target-minus-standard P3b peak amplitude (microvolts) and latency (ms) within 250-500 ms post-stimulus at midline electrodes - from 128-channel hdEEG during auditory and visual oddball tasks |
| Other | DAR-2 [subset of DAR-5] | baseline, pre-intervention, periprocedurally | EMA 2 items 5-pt Likert Score: 2-10 |
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
Read this list from software.
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