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

Sleep Disordered-breathing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01361854
• Other study ID #: AK/11-05-42/4024
• Status: Completed
• Phase: N/A
• First received: May 26, 2011
• Last updated: May 22, 2015
• Start date: August 2011
• Est. completion date: November 2014

Study information

• Verified date: May 2015
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• adult,

• suspects of SDB,

• leaving home,

• at maximum 30km around the hospital

Exclusion Criteria:

• suspicion of other sleep disorders

• children

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Sleep Disordered-breathing

Intervention

Device:
• polysomnography
home-based polysomnography with hook-up performed ar at home or in the hospital

Locations

Country	Name	City	State
Belgium	CHU Saint Pierre	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure Rate of Sleep Study	failure rate of polysomnography according to the hook-up protocol. Polysomnographies scored as "poor" or "unsatisafctory" according to Redline et al. SLEEP 1998 are considered as failed.	1 day	No