Sleep Health Enhancement in Midlife Adults
NCT06311500, Phase 1, Phase 2, Completed, University of Kansas Medical Center
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Sleep Health Enhancement in Midlife Adults | ClinicalTrials.gov |
| NCT number | NCT06311500 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 1, Phase 2 | ClinicalTrials.gov |
| Enrollment | 30 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Kansas Medical Center | ClinicalTrials.gov |
| Conditions | Sleep Health, Midlife Adults | ClinicalTrials.gov |
| Interventions | Sleep health enhancement intervention | ClinicalTrials.gov |
| First posted | 2024-03-15 | ClinicalTrials.gov |
| Last updated | 2025-12-26 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 6-item Acceptability Scale | immediately post-intervention | 5-point Likert scales on ease of use, understandability, enjoyment, perceived helpfulness, time commitment, and overall satisfaction | ClinicalTrials.gov |
| Primary | Qualitative interview | immediately post-intervention | semi-structured interview to assess acceptability | ClinicalTrials.gov |
| Primary | Ru-SATED Composite score | baseline, Week 6, Week 12 | Comprised of 6 subscores (regularity, timing, efficiency, and duration from actigraphy, satisfaction from sleep diary, and alertness from Epworth Sleepiness Scale) | ClinicalTrials.gov |
| Primary | Sleep Self-Efficacy Scale | baseline, Week 6, Week 12 | 9 item self-report Likert-scale questionnaire use to identify sleep self-efficacy. | ClinicalTrials.gov |
| Primary | Pittsburgh Sleep Quality Index | baseline, Week 6, Week 12 | used to assess quality of sleep | ClinicalTrials.gov |
| Primary | Epworth Sleepiness Scale | baseline, Week 6, Week 12 | used to assess daytime sleepiness | ClinicalTrials.gov |
| Primary | Dysfunctional Beliefs About Sleep (DBAS-10) consists of 10 statements reflecting beliefs and attitudes about sleep. Each statement is rated from 1 = strongly disagree to 10 = strongly agree | baseline, Week 6, Week 12 | The DBAS-10 used to identify dysfunctional beliefs about sleep | ClinicalTrials.gov |
| Primary | Positive Affect and Negative Affect Schedule | baseline, Week 6, Week 12 | 20-item self-report questionnaire used to measure positive and negative emotions | ClinicalTrials.gov |
| Primary | Continuous Performance Test | baseline, Week 6, Week 12 | requires participants to respond as quickly and accurately as possible to a series of stimuli that are delivered via computer. The participants will be instructed to tap the space bar for every letter except "X." | ClinicalTrials.gov |
| Primary | Stroop Test | baseline, Week 6, Week 12 | requires participants to inhibit the natural response (reading a word) and replace it with another response (saying a color) | ClinicalTrials.gov |
| Primary | Cognitive Failures Questionnaire | baseline, Week 6, Week 12 | assesses perception of cognitive abilities over the past 6 months | ClinicalTrials.gov |
| Primary | Actigraphy | baseline, Week 6, Week 12 | Participants will wear an actigraph on their non-dominant wrist for 7 nights to assess sleep/wake cycle. Mains variables of interest are sleep regularity, timing, efficiency, and duration. | 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 2
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 |
|---|---|---|
| Continuous Performance Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary 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)