Clinical trial NCT06675799: Pilot Sleep Extension and Mood
Official title: Sleep Extension to Improve Mood in Young Urban Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Internalizing Mental Health Symptoms
Sleep Problems
Keywords: young adults
sleep
mood
anxiety
depression
sleep extension
stress
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility
timeFrame: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
measure: Tolerability
timeFrame: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
measure: Acceptability
timeFrame: At end of 6-week intervention
measure: Sleep duration
timeFrame: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
measure: Sleep efficiency
timeFrame: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
measure: Waking after sleep onset (WASO)
timeFrame: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
measure: Subjective sleep quality
timeFrame: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
measure: Internalizing symptoms
timeFrame: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
Secondary outcomes:
measure: Daytime fatigue
timeFrame: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
measure: Bedtime Procrastination
timeFrame: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
measure: Electronics use before bed
timeFrame: Pre-treatment and at 6-week post-treatment assessment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
Study officials:
affiliation: University of Illinois Chicago
name: Jennifer Duffecy, PhD
role: PRINCIPAL_INVESTIGATOR
References: