Haemodialysis-induced SymptomNCT01327560
Sleep Quality and Related Factors in Hemodialysis Patients
An observational study of Haemodialysis-induced Symptom, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Haemodialysis-induced Symptom
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2011to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hemodialysis Patients
Who may be able to join
- 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.
Who cannot join
- Hospitalized hemodialysis patient in recently one month.
- Hemodialysis patient had conscious disturbance, blind or dementia.
- Hemodialysis Patient refuse to interview or fill out questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This study will be a cross-sectional design with purposive sample from 2 different dialysis medical centers in Taipei. Two hundred hemodialysis patients meeting inclusion criteria will be recruited.
- Conditions
- Haemodialysis-induced Symptom
- Keywords
- hemodialysis patients, sleep quality, restless legs syndrome, excessive daytime sleepiness, sleep apnea syndrome
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Restless Legs Syndrome, Disorders of Excessive Somnolence, Sleep Apnea Syndromes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study startFeb 2011
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemodialysis-induced SymptomStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Tso-Hsiao Chen, Principal investigator, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327560
- Sponsor's protocol ID
- 100003
- Status last verified
- Mar 2011
- First submitted
- 30 Mar 2011
- Last updated
- 1 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Quality and Related Factors in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01327560
- Acronym / sponsor ID
- 100003
- Conditions
- Haemodialysis-induced Symptom
- Keywords
- hemodialysis patients, sleep quality, restless legs syndrome, excessive daytime sleepiness, sleep apnea syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Study completion
- Dec 2011 (estimated)
- First posted
- 1 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will be a cross-sectional design with purposive sample from 2 different dialysis medical centers in Taipei. Two hundred hemodialysis patients meeting inclusion criteria will be recruited.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodialysis Patients
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Hospitalized hemodialysis patient in recently one month.
- Hemodialysis patient had conscious disturbance, blind or dementia.
- Hemodialysis Patient refuse to interview or fill out questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2011.
Related trials for Haemodialysis-induced Symptom
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Recruiting
ULtrafiltration-Rate Induced CArdiac Strain (ULRICA) - Study
Fluid Overload, Dialysis; Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tso-Hsiao Chen principal investigator
Taipei Medical University WanFang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemodialysis-induced Symptom, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2011.