Comparison of 2 Different Hook-up Protocols to Perform Home-based Polysomnography

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Centre Hospitalier Universitaire Saint Pierre
Sponsor:
Information provided by (Responsible Party):
Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier:
NCT01361854
First received: May 26, 2011
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

Comparison of 2 hook-up protocols to perform home-based sleep studies in patients suspected of sleep-disordered breathing.

First one: hook-up is performed in the hospital, around 4 PM, and the patient go home with the portable monitoring.

Second one: hook-up is performed home, around 7 PM, and the patient has not to move after hook-up.


Condition Intervention
Sleep Disordered-breathing
Device: polysomnography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Comparison of 2 Different Hook-up Protocols to Perform Home-based Polysomnography

Further study details as provided by Centre Hospitalier Universitaire Saint Pierre:

Primary Outcome Measures:
  • quality of sleep study [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    quality of polysomnography according to the hook-up protocol


Estimated Enrollment: 102
Study Start Date: August 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: polysomnography for suspicion of SDB
adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography
Device: polysomnography
home-based polysomnography with hook-up performed ar at home or in the hospital
Other Name: sleep study

Detailed Description:

All the patients will undergo 2 polysomnographies, according to two different hook-up protocols, within 2 weeks. Order of the exams will be randomized.

We hypothesised that quality of recording is better when hook-up is performed at home.

Final polysomnographic diagnosis, with the 2 different techniques, must be similar.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult,
  • suspects of SDB,
  • leaving home,
  • at maximum 30km around the hospital

Exclusion Criteria:

  • suspicion of other sleep disorders
  • children
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361854

Contacts
Contact: Marie Bruyneel, MD 3225354219 marie_bruyneel@stpierre-bru.be
Contact: Christina Sanida, MD 3225353232 sanida@medimarien.be

Locations
Belgium
CHU Saint Pierre Recruiting
Brussels, Belgium, 1000
Contact: marie bruyneel, MD    3225354219    marie_bruyneel@stpierre-bru.be   
Principal Investigator: marie Bruyneel, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre
Investigators
Principal Investigator: marie Bruyneel, MD CHU St Pierre
  More Information

No publications provided

Responsible Party: Marie Bruyneel, chest physician, Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier: NCT01361854     History of Changes
Other Study ID Numbers: AK/11-05-42/4024
Study First Received: May 26, 2011
Last Updated: May 13, 2014
Health Authority: Belgium: Ethics Committee

Keywords provided by Centre Hospitalier Universitaire Saint Pierre:
polysomnography
portable monitoring
sleep
sleep disordered breathing
home based polysomnography

Additional relevant MeSH terms:
Respiratory Aspiration
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 20, 2014