Sleep Health Enhancement in Midlife Adults

University of Kansas

Status and phase: Completed; Phase 2; Phase 1

Conditions: Sleep Health; Midlife Adults

Treatments: Behavioral: Sleep health enhancement intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06311500

STUDY00151143

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 45 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Sleep Health Enhancement Intervention

Experimental group

Description:

4 weekly visits using Zoom video conferencing consisting of education and strategies to enhance sleep health with each visit lasting about 60 minutes.

Treatment:

Behavioral: Sleep health enhancement intervention

Wait-List Control Group

No Intervention group

Description:

People in the wait-list group will continue with their usual activities for 4 weeks and then start the sleep health enhancement intervention.