NCT05093465

Brief Summary

The study was a randomized controlled trial designed to examine whether augmenting traditional sleep hygiene and stimulus control procedures with technology use reduction stimulus control procedures would produce better sleep and technology usage outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

10 months

First QC Date

October 14, 2021

Last Update Submit

October 25, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Sleep Quality

    Scores on the Pittsburgh Sleep Quality Index

    From baseline to posttest, approximately 5 weeks

  • Technology Usage

    Self-reported usage of various forms of technology in minutes

    From baseline to posttest, approximately 5 weeks

Secondary Outcomes (2)

  • Sleep Hygiene

    From baseline to posttest, approximately 5 weeks

  • Sleep Control

    From baseline to posttest, approximately 5 weeks

Study Arms (2)

Active Control

ACTIVE COMPARATOR

Participants were provided with sleep hygiene and stimulus control procedures.

Other: Active Control

Technology Intervention

EXPERIMENTAL

Participants were given the same intervention materials as the active control condition plus procedures to change technology use.

Behavioral: Technology Intervention

Interventions

Participants were provided with sleep hygiene and stimulus control procedure plus procedures to reduce technology usage in bed (i.e., technology usage stimulus control). In addition to the sleep hygiene and stimulus control procedures, participants were also given a set of procedures aimed at changing technology usage behavior at bedtime and throughout the day.

Technology Intervention

Participants were provided with sleep hygiene and stimulus control procedures.

Active Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be at least 18 years old, enrolled at Oakland University, and reside in an on-campus dormitory to participate.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oakland University

Rochester, Michigan, 48309, United States

Location

MeSH Terms

Conditions

ParasomniasSleep Hygiene

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersHealth BehaviorBehavior

Study Officials

  • Andrea T Kozak, PhD

    Oakland University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2021

First Posted

October 26, 2021

Study Start

September 25, 2018

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

October 26, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations