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Behavioral Intervention for Sleep (RESET-SLEEP Trial)

N/A

Waitlist Available

Led By Christopher E Kline, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

RESET-SLEEP Trial Summary

This trial will study the impact of reducing sedentary behavior on blood pressure, by examining the link between sleep and sedentary behavior.

Eligible Conditions

Sleep
Insomnia
Obstructive Sleep Apnea

RESET-SLEEP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline actigraphic wake after sleep onset (WASO) at 3 months

Change from baseline activPAL-assessed sedentary behavior (SED) at 3 months

Change from baseline resting systolic blood pressure (SBP) at 3 months

Secondary outcome measures

Change from baseline 24-hour blood pressure at 3 months

Change from baseline apnea-hypopnea index (AHI) at 3 months

Change from baseline pulse wave velocity (PWV) at 3 months

+2 more

Other outcome measures

Change from baseline Epworth Sleepiness Scale (ESS) scores at 3 months

Change from baseline Functional Outcomes of Sleep Questionnaire (FOSQ) scores at 3 months

Change from baseline Insomnia Severity Index (ISI) scores at 3 months

+9 more

Side effects data

From 2013 Phase 1 & 2 trial • 16 Patients • NCT01923896

13%

Diarrhea

100%

80%

60%

40%

20%

Study treatment Arm

Behavioral Intervention & DCS

Behavioral Intervention & Placebo

RESET-SLEEP Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Behavioral InterventionExperimental Treatment1 Intervention

The intervention will use behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts to target a 2-4 hour/day reduction in sedentary behavior.

Group II: Control ConditionActive Control1 Intervention

Participants randomized to the control condition will receive no intervention during the study. After the 3-month assessment, control participants will be provided with a wrist-worn activity monitor and will be offered the 3-month delayed intervention if desired to aid in retention and recruitment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Behavioral Intervention

2021

Completed Phase 4

~3740

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,831 Previous Clinical Trials

47,305,916 Total Patients Enrolled

31 Trials studying Sleep

56,897 Patients Enrolled for Sleep

University of PittsburghLead Sponsor

1,719 Previous Clinical Trials

16,342,165 Total Patients Enrolled

14 Trials studying Sleep

1,910 Patients Enrolled for Sleep

Christopher E Kline, PhDPrincipal InvestigatorAssistant Professor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the purpose of this exploration?

"The primary outcome of this trial, measured over a 3-month period, is the alteration in sedentary behaviour as assessed by activPAL. Secondary objectives include changes to apnea hypopnoea index (AHI) monitored via polysomnography during 1 night at home; 24 hour blood pressure readings from an ambulatory monitor taken during work and rest hours respectively, and pulse wave velocity (PWV) evaluated through tonometry following 10 minutes relaxation."

Answered by AI

Is this research program open to participants younger than four decades old?

"As indicated by the study's admission requirements, participants must be aged between 21 and 65 years old."

Answered by AI

Are there currently any opportunities for volunteers to join this experiment?

"This medical trial, which was recently updated on February 2nd 2022 is not actively recruiting participants. Clinicaltrials.gov states that this study has been posted since May 6th 2019; however there are currently 511 other trials looking for candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reducing Sedentary Behavior to Improve Sleep: an Ancillary Study to the RESET BP Clinical Trial

Christopher Kline 2019. "Reducing Sedentary Behavior to Improve Sleep: an Ancillary Study to the RESET BP Clinical Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03946228.