Sleep Enhancement Training Study for Experienced Shiftworkers

This study is currently recruiting participants.

Verified by University of California, San Francisco, November 2008

First Received: November 4, 2008 No Changes Posted

Sponsors and Collaborators:	University of California, San Francisco National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00786357

Purpose

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 shiftworking nurses.

Condition	Intervention	Phase
Shift-Work Sleep Disorder	Behavioral: NIOSH shiftwork booklet Behavioral: Sleep Enhancement Training System	Phase I

Study Type:	Interventional
Study Design:	Treatment, Double Blind (Subject, Outcomes Assessor), Single Group Assignment, Efficacy Study
Official Title:	Sleep Enhancement Training Study for Experienced Shiftworkers

Resource links provided by NLM:

MedlinePlus related topics: Sleep Disorders

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	30
Study Start Date:	November 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

English-speaking female nurses working full-time and scheduled to work at least 2 consecutive night shifts per week during the next 3 months
postmenopausal (no menstrual periods in the past 12 months
≥40 years of age
experiencing disturbed sleep related to night-shift at least 3 times per week for the last month

Exclusion Criteria:

currently experiencing menopausal vasomotor symptoms (i.e, hot flashes or night sweats)
started hormone therapy in the last 12 months
history of diagnosed sleep disorder or affective illness
sleep disturbance due to environmental factors (e.g., partner, children, or pets)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00786357

Contacts

Contact: Traci Coggins	415-476-4435	traci.coggins@ucsf.edu
Contact: Caryl Gay, PhD	415-476-4435	caryl.gay@ucsf.edu

Locations

United States, California
University of California, San Francisco	Recruiting
San Francisco, California, United States, 94143
Sub-Investigator: Kathryn A. Lee, RN, PhD

Sponsors and Collaborators

University of California, San Francisco

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Christopher R. Alsten, PhD

Inner Health, Inc

More Information

No publications provided

Responsible Party:	Inner Health, Inc ( Christopher Alsten, PhD, Executive Vice President )
Study ID Numbers:	R43-HL090110
Study First Received:	November 4, 2008
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00786357 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

shift-work
sleep
nurse
relaxation

Study placed in the following topic categories:

Signs and Symptoms
Sleep Disorders, Circadian Rhythm
Mental Disorders
Neurologic Manifestations
Disorders of Environmental Origin

Dyssomnias
Sleep Disorders
Occupational Diseases
Chronobiology Disorders

Additional relevant MeSH terms:

Signs and Symptoms
Sleep Disorders, Circadian Rhythm
Mental Disorders
Nervous System Diseases
Neurologic Manifestations

Disorders of Environmental Origin
Dyssomnias
Sleep Disorders
Occupational Diseases
Chronobiology Disorders

ClinicalTrials.gov processed this record on July 06, 2009