Sleep Enhancement Training Study for Experienced Shiftworkers (SETS-exp)

This study has been completed.

Sponsor:

Collaborator:

National Heart, Lung, and Blood Institute (NHLBI)

Information provided by:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT00786357

First received: November 4, 2008

Last updated: June 22, 2010

Last verified: June 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

November 4, 2008

Last Updated Date

June 22, 2010

Start Date ^ICMJE

November 2008

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

actigraphy measures of sleep [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00786357 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

subjective measures of sleep and well-being [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Sleep Enhancement Training Study for Experienced Shiftworkers

Official Title ^ICMJE

Sleep Enhancement Training Study for Experienced Shiftworkers

Brief Summary

The purpose of this study is to determine if a modified version of the Sleep Enhancement Fatigue Reduction Training (SEFRT) system can improve sleep and health-related symptoms and quality of life in experienced shift-working nurses.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Shift-Work Sleep Disorder

Intervention ^ICMJE

Behavioral: NIOSH shiftwork booklet
weekly readings about coping with shiftwork
Behavioral: Sleep Enhancement Training System
4 week program of readings and relaxation programs

Study Arm (s)

Experimental: Intervention

Interventions:

Behavioral: NIOSH shiftwork booklet
Behavioral: Sleep Enhancement Training System

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2010

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

English-speaking nurses
scheduled to work at least 2 consecutive night shifts per week during the next 3 months
≥40 years of age
experiencing disturbed sleep related to night-shift

Exclusion Criteria:

current diagnosis of sleep disorder or affective illness

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00786357

Other Study ID Numbers ^ICMJE

SETS-exp

Has Data Monitoring Committee

Responsible Party

Christopher Alsten, PhD, Executive Vice President, Inner Health, Inc

Study Sponsor ^ICMJE

University of California, San Francisco

Collaborators ^ICMJE

National Heart, Lung, and Blood Institute (NHLBI)

Investigators ^ICMJE

Principal Investigator:

Christopher R. Alsten, PhD

Inner Health, Inc.

Information Provided By

University of California, San Francisco

Verification Date

June 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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