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

Centre Hospitalier Universitaire Saint Pierre

Status: Completed

Conditions: Sleep Disordered-breathing

Treatments: Device: polysomnography

Study type: Interventional

Funder types: Other

Identifiers

NCT01361854

AK/11-05-42/4024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• suspicion of other sleep disorders
• children

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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102 participants in 1 patient group

polysomnography for suspicion of SDB

Experimental group

Description:

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

Treatment:

Device: polysomnography