Pilot Sleep Extension and Mood

Not Applicable

Active, not recruiting

• Conditions: Internalizing Mental Health Symptoms; Sleep Problems

• Registration Number: NCT06675799
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

The goal of this interventional study is to learn if a digital sleep extension intervention can improve sleep and mood in young urban adults with mood symptoms. The main questions it aims to answer are:

Will this intervention improve sleep? Will this intervention improve mood? Does the effect of this intervention change based on environmental factors like noise and light pollution?

Researchers will compare participants receiving the sleep intervention to participants receiving a "general healthy living" intervention to see if outcome are different across groups.

Participants will:

* receive 6 weeks of brief once weekly telephone coaching and read once weekly educational content

* have their sleep monitored daily with a FitBit and Somnofy sleep device and during the 6-week intervention period

* respond to questionnaires at the start of the intervention, halfway through the intervention, at the end of the intervention, and finally 4 weeks after completing the intervention

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-11-04
• Study First Posted: 2024-11-05
• Study Start: 2025-01-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-09-15
• Last Update Posted: 2025-09-17
• Primary Completion: 2025-09-30
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Age 18 to 30
• Have internalizing symptoms (e.g., depression, anxiety, stress)
• Have sleep concerns
• Sleep less than 7 hours per night
• Have perceived neighborhood disorder
• Smart phone that can run Somnofy app
• Access to Wifi in their home

Exclusion Criteria

• High risk for obstructive sleep apnea
• Significant medical morbidities or psychiatric problem, or chronic substance use
• Non-English speaking (unable to participate in therapy or questionnaire)
• Taking medications for sleep
• An insomnia disorder
• Traveling for 2 weeks or more during the 10-week study period (due to loss of data from participants not sleeping in their home where the Somnofy device has been set up)
• Employed with rotating shift or night work

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility	From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)	Measured by the number of participants approached, recruited and retained
Tolerability	From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)	Measured by sessions completed
Acceptability	At end of 6-week intervention	Acceptability of Intervention Measure
Sleep duration	From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)	Measured by Fitbit
Sleep efficiency	From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)	Measured by Fitbit
Waking after sleep onset (WASO)	From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)	Measured by Fitbit
Subjective sleep quality	From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)	Measured with the Pittsburgh Sleep Quality Index (PSQI), where higher scores indicate poorer sleep quality.
Internalizing symptoms	From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)	Anxiety, depression, and stress as measured with the Depression, Anxiety and Stress Scale - 21 item (DASS-21), where higher scores mean more distress.

Secondary Outcome Measures

Name	Time	Method
Daytime fatigue	From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)	PROMS-Fatigue 8 item
Bedtime Procrastination	From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)	Bedtime Procrastination Scale where higher scores equal more procrastination.
Electronics use before bed	Pre-treatment and at 6-week post-treatment assessment	2 items taken from National Sleep Foundation 2011 Sleep in America survey

Trial Locations

Locations (1)

University of Illinois Chicago; 🇺🇸 Chicago, Illinois, United States