Sleep Disordered-breathing
Conditions
Keywords
polysomnography, portable monitoring, sleep, sleep disordered breathing, home based polysomnography
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.
Interventions
DEVICEpolysomnography
home-based polysomnography with hook-up performed ar at home or in the hospital
Sponsors
Centre Hospitalier Universitaire Saint Pierre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* adult, * suspects of SDB, * leaving home, * at maximum 30km around the hospital
Exclusion criteria
* suspicion of other sleep disorders * children
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure Rate of Sleep Study | 1 day | 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. |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Polysomnography for Suspicion of SDB adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography
polysomnography: home-based polysomnography with hook-up performed ar at home or in the hospital | 102 |
| Total | 102 |
Baseline characteristics
| Characteristic | Polysomnography for Suspicion of SDB |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 102 Participants |
| Age, Continuous | 48 years STANDARD_DEVIATION 12 |
| Region of Enrollment Belgium | 102 participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 51 | 0 / 48 |
| serious Total, serious adverse events | 0 / 51 | 0 / 48 |
Outcome results
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.
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Home Hook up First | Failure Rate of Sleep Study | 6 percentage of participants |
| Lab Hook up First | Failure Rate of Sleep Study | 6 percentage of participants |