NCT00786266

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 shiftwork-naive new nurse graduates.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2008

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

June 23, 2010

Status Verified

June 1, 2010

Enrollment Period

1.5 years

First QC Date

November 4, 2008

Last Update Submit

June 22, 2010

Conditions

Shift-Work Sleep Disorder

Keywords

shift-worksleepnurserelaxation

Outcome Measures

Primary Outcomes (1)

  • actigraphy measures of sleep

    6 weeks

Secondary Outcomes (1)

  • subjective measures of sleep and well-being

    6 weeks

Study Arms (2)

NIOSH shiftwork booklet

ACTIVE COMPARATOR
Behavioral: NIOSH shiftwork booklet

Sleep Enhancement Training System

EXPERIMENTAL
Behavioral: Sleep Enhancement Training System

Interventions

Sleep Enhancement Training SystemBEHAVIORAL

4 week program of readings and relaxation programs

Sleep Enhancement Training System
NIOSH shiftwork bookletBEHAVIORAL

weekly readings about coping with shiftwork

NIOSH shiftwork booklet

Eligibility Criteria

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

You may qualify if:

  • English-speaking nurses scheduled to work at least 2 consecutive night shifts per week in the next 2 months

You may not qualify if:

  • \> 6 months experience working night-shift
  • current diagnosis of sleep disorder or affective illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Chronobiology DisordersNervous System DiseasesDyssomniasSleep Wake DisordersOccupational DiseasesMental Disorders

Study Officials

  • Christopher R Alsten, PhD

    Inner Health, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 4, 2008

First Posted

November 6, 2008

Study Start

November 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

June 23, 2010

Record last verified: 2010-06

Locations

US(1)