EEG Markers From Polysomnography and Cognitive Performance in Obstructive Sleep Apnea
NCT07897474, Not yet recruiting, University of Split, School of Medicine
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | EEG Markers From Polysomnography and Cognitive Performance in Obstructive Sleep Apnea | ClinicalTrials.gov |
| NCT number | NCT07897474 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 100 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Split, School of Medicine | ClinicalTrials.gov |
| Conditions | Obstructive Sleep Apnea, Cognitive Impairment | ClinicalTrials.gov |
| Interventions | Full-night polysomnography with EEG marker analysis and cognitive testing | ClinicalTrials.gov |
| First posted | 2026-10-27 | ClinicalTrials.gov |
| Last updated | 2026-10-27 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Correlation between sleep spindle density and Montreal Cognitive Assessment (MoCA) total score | Single assessment at baseline (at study enrollment), on the day of the overnight PSG. | The correlation between sleep spindle density, quantified from full-night polysomnography (PSG), and global cognitive performance assessed using the Montreal Cognitive Assessment (MoCA; total score, 0-30 points, with higher scores indicating better cognitive performance). The correlation will be assessed using Pearson's or Spearman's correlation coefficient, as appropriate. The correlation coefficient (r) and its 95% confidence interval will be reported. An adjusted multiple linear regression analysis will additionally assess the relationship between sleep spindle density and MoCA total score, controlling for age, sex, body mass index, education, and daytime sleepiness. | ClinicalTrials.gov |
| Primary | Correlation between sleep spindle density and Digit Span Test forward score | Single assessment at baseline (at study enrollment), on the day of the overnight PSG. | The correlation between sleep spindle density, quantified from full-night polysomnography (PSG), and Digit Span Test forward performance, measured as the maximum span length (number of digits correctly recalled). Higher scores indicate better performance. Pearson's or Spearman's correlation coefficient, as appropriate, and its 95% confidence interval will be reported. Multiple linear regression adjusted for age, sex, body mass index, education, and daytime sleepiness will additionally be performed. | ClinicalTrials.gov |
| Primary | Correlation between sleep spindle density and Psychomotor Vigilance Test (PVT) mean reaction time | Single assessment at baseline (at study enrollment), on the day of the overnight PSG. | The correlation between sleep spindle density, quantified from full-night polysomnography (PSG), and mean reaction time on the Psychomotor Vigilance Test (PVT), measured in milliseconds (ms). Shorter reaction times indicate better sustained attention. Pearson's or Spearman's correlation coefficient, as appropriate, and its 95% confidence interval will be reported. Multiple linear regression adjusted for age, sex, body mass index, education, and daytime sleepiness will additionally be performed. | ClinicalTrials.gov |
| Primary | Correlation between sleep spindle density and Trail Making Test Part A (TMT-A) completion time | Single assessment at baseline (at study enrollment), on the day of the overnight PSG. | The correlation between sleep spindle density, quantified from full-night polysomnography (PSG), and TMT-A completion time, measured in seconds. Shorter completion times indicate better processing speed. Pearson's or Spearman's correlation coefficient, as appropriate, and its 95% confidence interval will be reported. Multiple linear regression adjusted for age, sex, body mass index, education, and daytime sleepiness will additionally be performed. | ClinicalTrials.gov |
| Primary | Correlation between sleep spindle density and Stroop Test interference-condition completion time | Single assessment at baseline (at study enrollment), on the day of the overnight PSG. | The correlation between sleep spindle density, quantified from full-night polysomnography (PSG), and completion time for the interference condition of the Stroop Test, measured in seconds. Shorter completion times indicate better performance. Pearson's or Spearman's correlation coefficient, as appropriate, and its 95% confidence interval will be reported. Multiple linear regression adjusted for age, sex, body mass index, education, and daytime sleepiness will additionally be performed. | ClinicalTrials.gov |
| Primary | Correlation between sleep spindle density and Digit Symbol Substitution Test (DSST) score | Single assessment at baseline (at study enrollment), on the day of the overnight PSG. | The correlation between sleep spindle density, quantified from full-night polysomnography (PSG), and the Digit Symbol Substitution Test (DSST) score, measured as the number of correctly completed symbol substitutions according to the test scoring rules. Higher scores indicate better processing speed. Pearson's or Spearman's correlation coefficient, as appropriate, and its 95% confidence interval will be reported. Multiple linear regression adjusted for age, sex, body mass index, education, and daytime sleepiness will additionally be performed. | ClinicalTrials.gov |
| Secondary | Variance in cognitive test scores explained by a multivariable model including all three EEG markers | Single assessment at baseline (at study enrollment), on the day of the overnight PSG. | Exploratory multiple linear regression models will assess the combined contribution of sleep spindle density, K-complex density, and REM EEG slowing to cognitive test performance. Separate models will be fitted for each prespecified cognitive outcome: MoCA total score, Digit Span forward and backward scores, PVT mean reaction time, TMT-A and TMT-B completion times, TMT B-A difference score, prespecified Stroop Test measures, and DSST score. Models will be adjusted for age, sex, body mass index, education, and daytime sleepiness. The combined contribution of the EEG markers will be summarized using the coefficient of determination (R²), adjusted R², regression coefficients, and their 95% confidence intervals, as appropriate. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Primary outcome | ConductCognition |
| Psychomotor Vigilance Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Symbol Coding | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)