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OpenTrials
Completed

NCT Number: NCT06675799

Pilot Sleep Extension and Mood

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

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Key information

Conditions

Internalizing Mental Health Symptoms Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Nervous System Diseases Parasomnias Sleep Problems Sleep Wake Disorders

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep Extension

Behavioral

Weekly educational material about sleep health and weekly brief phone coaching calls for a total of 6 weeks.

Healthy Living Psychoeducation

Behavioral

Weekly educational materials about healthy habits and weekly brief phone calls to clarify terms or concepts.

Primary outcomes

  1. Feasibility

    Time frame: 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

  2. Tolerability

    Time frame: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)

    Measured by sessions completed

  3. Acceptability

    Time frame: At end of 6-week intervention

    Acceptability of Intervention Measure

  4. Sleep duration

    Time frame: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)

    Measured by Fitbit

  5. Sleep efficiency

    Time frame: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)

    Measured by Fitbit

  6. Waking after sleep onset (WASO)

    Time frame: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)

    Measured by Fitbit

  7. Subjective sleep quality

    Time frame: 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.

  8. Internalizing symptoms

    Time frame: 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 outcomes

  1. Daytime fatigue

    Time frame: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)

    PROMS-Fatigue 8 item

  2. Bedtime Procrastination

    Time frame: 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.

  3. Electronics use before bed

    Time frame: Pre-treatment and at 6-week post-treatment assessment

    2 items taken from National Sleep Foundation 2011 Sleep in America survey

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Official study title

Sleep Extension to Improve Mood in Young Urban Adults

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 5, 2024
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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