NCT01327560

Brief Summary

Sleep quality is an important predictor of healthy status,quality of life and life span. Sleeping problems affect 50%\~80% in hemodialysis patients. Sleep quality and related factors research in hemodialysis patients has been discussed and studied globally. Previous studies show insomnia, excessive daytime sleepiness(EDS), sleep apnea syndrome(SAS), restless legs syndrome(RLS) are major causes of poor sleep quality . There is few data to show the influential factors related to sleep quality in Taiwanese hemodialysis patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 1, 2011

Status Verified

March 1, 2011

First QC Date

March 30, 2011

Last Update Submit

March 31, 2011

Conditions

Haemodialysis-induced Symptom

Keywords

hemodialysis patientssleep qualityrestless legs syndromeexcessive daytime sleepinesssleep apnea syndrome

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hemodialysis Patients

You may qualify if:

  • Hemodialysis patient whose age ≧ 20 years old and conscious clear.
  • ICD9：585.6
  • Every week receives two or three convention hemodialysis treatment above three months.
  • May communication with Mandarin or Taiwanese language.
  • Patient or caregiver is willing to participate study and sign the inform consent.

You may not qualify if:

  • Hospitalized hemodialysis patient in recently one month.
  • Hemodialysis patient had conscious disturbance, blind or dementia.
  • Hemodialysis Patient refuse to interview or fill out questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University - WanFang Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersRestless Legs SyndromeDisorders of Excessive SomnolenceSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersParasomniasApneaRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Tso-Hsiao Chen

    Taipei Medical University WanFang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 30, 2011

First Posted

April 1, 2011

Study Start

February 1, 2011

Study Completion

December 1, 2011

Last Updated

April 1, 2011

Record last verified: 2011-03

Locations

TW(1)