COMPLETED

Sleep Health Enhancement in Midlife Adults

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Despite the strong links between sleep and AD, a sleep health enhancement has yet to be targeted in mid-life adults (45-64 years old) to delay or prevent AD. An intervention aimed at enhancing sleep health is a critical opportunity for primary prevention to potentially delay the onset of AD. The objective of the proposed study is to develop and assess the feasibility, acceptability, and treatment effect of a comprehensive sleep health intervention (SHI) on improving sleep health in mid-life adults

Official Title

Sleep Health Enhancement in Midlife Adults

Quick Facts

Study Start:2024-02-13

Study Completion:2025-11-19

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06311500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 64 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 45-64 years old * ≤ 7 on the RU-SATED self-report questionnaire * MMSE ≥25 and AD8 \<3	* Known untreated sleep disorder (such as sleep apnea or restless leg syndrome) * \>3 on the STOP BANG indicating increased risk of sleep apnea * Increased risk of restless legs syndrome on RLS-Diagnosis Index * Evidence of circadian rhythm sleep-wake disorder * Evidence of parasomnia * Regular use (\>2x/week) of prescription or over-the-counter medications to improve sleep * Score of ≥15 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorsement of any suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9) * Score of ≥10 on the Generalized Anxiety Disorder (GAD-7) indicating moderate to severe anxiety * Self-report of current or history (up to 2 years) of drug or alcohol abuse based on the DSM-5-TR criteria * History of nervous system disorder such as stroke or Parkinson's disease * Severe mental illness such as schizophrenia or bipolar disorder * Current or history (within 5 years) of shift work including hours of midnight-4am * Is currently receiving a behavioral sleep health intervention

Inclusion Criteria

Exclusion Criteria

* 45-64 years old
* ≤ 7 on the RU-SATED self-report questionnaire
* MMSE ≥25 and AD8 \<3

* Known untreated sleep disorder (such as sleep apnea or restless leg syndrome)
* \>3 on the STOP BANG indicating increased risk of sleep apnea
* Increased risk of restless legs syndrome on RLS-Diagnosis Index
* Evidence of circadian rhythm sleep-wake disorder
* Evidence of parasomnia
* Regular use (\>2x/week) of prescription or over-the-counter medications to improve sleep
* Score of ≥15 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorsement of any suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)
* Score of ≥10 on the Generalized Anxiety Disorder (GAD-7) indicating moderate to severe anxiety
* Self-report of current or history (up to 2 years) of drug or alcohol abuse based on the DSM-5-TR criteria
* History of nervous system disorder such as stroke or Parkinson's disease
* Severe mental illness such as schizophrenia or bipolar disorder
* Current or history (within 5 years) of shift work including hours of midnight-4am
* Is currently receiving a behavioral sleep health intervention

Contacts and Locations

Study Locations (Sites)

University of Kansas Medical Center

Kansas City, Kansas, 66160

United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-13

Study Completion Date2025-11-19

Study Record Updates

Study Start Date2024-02-13

Study Completion Date2025-11-19

Terms related to this study

Additional Relevant MeSH Terms

Sleep Health
Midlife Adults