Clinical trial NCT06311500: Sleep Health Enhancement in Midlife Adults
Official title: Sleep Health Enhancement in Midlife Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Sleep Health
Midlife Adults
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 6-item Acceptability Scale
timeFrame: immediately post-intervention
measure: Qualitative interview
timeFrame: immediately post-intervention
measure: Ru-SATED Composite score
timeFrame: baseline, Week 6, Week 12
measure: Sleep Self-Efficacy Scale
timeFrame: baseline, Week 6, Week 12
measure: Pittsburgh Sleep Quality Index
timeFrame: baseline, Week 6, Week 12
measure: Epworth Sleepiness Scale
timeFrame: baseline, Week 6, Week 12
measure: 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
timeFrame: baseline, Week 6, Week 12
measure: Positive Affect and Negative Affect Schedule
timeFrame: baseline, Week 6, Week 12
measure: Continuous Performance Test
timeFrame: baseline, Week 6, Week 12
measure: Stroop Test
timeFrame: baseline, Week 6, Week 12
measure: Cognitive Failures Questionnaire
timeFrame: baseline, Week 6, Week 12
measure: Actigraphy
timeFrame: baseline, Week 6, Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
References: