Sleep Enhancement Training Study for Experienced Shiftwor... | NCT00786357

Studies
Sleep Enhancement Training Study for Experienced Shiftworkers

NCT00786357

Sponsor

University of California, San Francisco

Status

Completed

Last Update Posted

Jun 23, 2010Estimated

Enrollment

32Actual

Phase

Phase 1

Conditions

Shift-Work Sleep Disorder

Interventions

NIOSH shiftwork booklet
Sleep Enhancement Training System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Nov 4, 2008

First Submission Date that Met QC Criteria

Nov 4, 2008

First Posted Date

Nov 6, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2010

Last Update Posted Date

Jun 23, 2010Estimated

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental		Behavioral: NIOSH shiftwork booklet Behavioral: Sleep Enhancement Training System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NIOSH shiftwork booklet	Behavioral	weekly readings about coping with shiftwork	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
actigraphy measures of sleep		3 months

Secondary Outcomes

Measure	Description	Time Frame
subjective measures of sleep and well-being		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher R. Alsten, PhD	Inner Health, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Francisco		San Francisco	California	94143	United States

Condition Browse Module

MeSH Terms

ID	Term
D020178	Sleep Disorders, Circadian Rhythm

Ancestor Terms

ID	Term
D021081	Chronobiology Disorders
D009422	Nervous System Diseases
D020920	Dyssomnias
D012893	Sleep Wake Disorders

Browse Leaves

Not provided

Browse Branches

Not provided