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

NCT ID: NCT01361854

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2014-11-30

Brief 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.

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.

Conditions

Sleep Disordered-breathing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

polysomnography for suspicion of SDB

adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography

Group Type: EXPERIMENTAL

polysomnography

Intervention Type: DEVICE

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

Interventions

polysomnography

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

Intervention Type: DEVICE

Other Intervention Names

sleep study

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• suspicion of other sleep disorders
• children

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Saint Pierre

OTHER

Sponsor Role: lead

Responsible Party

Marie Bruyneel

chest physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

marie Bruyneel, MD

Role: PRINCIPAL_INVESTIGATOR

CHU St Pierre

Locations

CHU Saint Pierre

Brussels, , Belgium

Countries

Belgium

Other Identifiers

AK/11-05-42/4024

Identifier Type: -

Identifier Source: org_study_id