Sleep Health Enhancement in Midlife Adults

Sleep Health Clinical Trial

Official title:

Sleep Health Enhancement in Midlife Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06311500
• Other study ID #: STUDY00151143
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 13, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: University of Kansas Medical Center
• Contact: Catherine Siengsukon, PhD
• Phone: 913-588-6913
• Email: csiengsukon[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Health

Intervention

Behavioral:
• Sleep health enhancement intervention
4 weekly visits of education and strategies to enhance sleep health

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-item Acceptability Scale	5-point Likert scales on ease of use, understandability, enjoyment, perceived helpfulness, time commitment, and overall satisfaction	immediately post-intervention
Primary	Qualitative interview	semi-structured interview to assess acceptability	immediately post-intervention
Primary	Ru-SATED Composite score	Comprised of 6 subscores (regularity, timing, efficiency, and duration from actigraphy, satisfaction from sleep diary, and alertness from Epworth Sleepiness Scale)	baseline, Week 6, Week 12
Primary	Sleep Self-Efficacy Scale	9 item self-report Likert-scale questionnaire use to identify sleep self-efficacy.	baseline, Week 6, Week 12
Primary	Pittsburgh Sleep Quality Index	used to assess quality of sleep	baseline, Week 6, Week 12
Primary	Epworth Sleepiness Scale	used to assess daytime sleepiness	baseline, Week 6, Week 12
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	The DBAS-10 used to identify dysfunctional beliefs about sleep	baseline, Week 6, Week 12
Primary	Positive Affect and Negative Affect Schedule	20-item self-report questionnaire used to measure positive and negative emotions	baseline, Week 6, Week 12
Primary	Continuous Performance Test	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."	baseline, Week 6, Week 12
Primary	Stroop Test	requires participants to inhibit the natural response (reading a word) and replace it with another response (saying a color)	baseline, Week 6, Week 12
Primary	Cognitive Failures Questionnaire	assesses perception of cognitive abilities over the past 6 months	baseline, Week 6, Week 12
Primary	Actigraphy	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.	baseline, Week 6, Week 12