Recruiting
Early Phase 1

Personalized SMS

Sponsor:

University of Missouri, St. Louis

Code:

NCT05108194

Conditions

Insomnia

Sleep Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SMS Personalized Sleep Intervention

Study Details

Brief summary:

The goal of this research is to establish a proof of concept for optimizing and evaluating a personalized SMS intervention based for individuals with chronic sleep problems.

Conditions

Insomnia

Sleep Disorder

Study ID

NCT05108194

Start date

Nov 15, 2021

Status verified date

Apr, 2022

Completion date

Jun 1, 2022

Anticipated

Primary completion date

Jun 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • clinical insomnia (defined by scoring ≥ 15 on the insomnia severity index)

Exclusion Criteria:

  • under 18 y.o.
  • unable to read or write in English
  • do not own a Smart Phone

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1: Intervention

Participants (N=50) who endorse insomnia will be followed for 8 weeks. All participants will be asked to download a separate app to passively monitor sleep that will inform the personalized messages. Participants will also be asked to respond to daily prompts in order to validate the passive sleep data. The study includes two phases: (1) a training and validation phase and (2) an intervention phase. During phase 1, participants' sleep habits and other behaviors will be monitored for two weeks in order to validate and optimize the SMS personalized sleep intervention (PSI). In phase 2, participants will be transitioned to the intervention phase of the study.

Interventions

SMS Personalized Sleep Intervention

All participants will be enrolled in the intervention to evaluate the feasibility and acceptability of the SMS-PSI. After the data training and validation phase, participants will be provided with at least one and up to three daily text messages that offer users a specific strategy based on strategies from CBTi. All participants will have access to a "user dashboard", which is a web-app that includes personalized sleep-tracking information and the opportunity to customize their messaging. The person-level acceptability and adherence to the sleep strategies will be evaluated via self-report endorsement from daily diary and whether users added suggestions to their calendars. Both adherence and acceptability will be collected and integrated with the selection algorithm to optimize subsequent SMS suggestions.

Primary outcome measure

  • Insomnia Severity Index [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Missouri-St Louis

Recruiting

Saint Louis, Missouri, United States, 63121

More Information

Sponsor

University of Missouri, St. Louis

Last update posted

Apr 25, 2022

Last verified

Apr, 2022

Keywords

  • Insomnia
  • Sleep

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri, St. Louis on 2022-04-25.