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Pilot Sleep Extension and Mood

Sleep Extension to Improve Mood in Young Urban Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06675799
Enrollment
19
Registered
2024-11-05
Start date
2025-01-01
Completion date
2025-11-01
Last updated
2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Internalizing Mental Health Symptoms, Sleep Problems

Keywords

young adults, sleep, mood, anxiety, depression, sleep extension, stress

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

Interventions

BEHAVIORALSleep Extension

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

BEHAVIORALHealthy Living Psychoeducation

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

Sponsors

University of Illinois at Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Internalizing symptomsFrom 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.
Sleep efficiencyFrom 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 qualityFrom 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.
FeasibilityFrom 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
TolerabilityFrom enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)Measured by sessions completed
AcceptabilityAt end of 6-week interventionAcceptability of Intervention Measure
Sleep durationFrom enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)Measured by Fitbit

Secondary

MeasureTime frameDescription
Bedtime ProcrastinationFrom 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 bedPre-treatment and at 6-week post-treatment assessment2 items taken from National Sleep Foundation 2011 Sleep in America survey
Daytime fatigueFrom enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)PROMS-Fatigue 8 item

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026