Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424658
Status:
COMPLETED
Last Update Posted:
2015-04-01
First Post:
2007-01-17
Brief Title:
Sleep Apnea Concordance Between Non-reference and Reference Centres
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
When a disorder is as prevalent as sleep apnea hypopnea syndrome various medical levels and strategies should be implicated We to evaluate the degree of concordance in management between a sleep reference centre and non-reference centres
Detailed Description:
INTRODUCTION When a disorder is as prevalent as SAHS different medical levels should be involved to facilitate diagnosis for all patients or at least those that are in moderate-severe or risk groups A good option could be to transfer the patient assessment to non-reference centres NRC Therefore the aim of the present study was to evaluate this strategy by analysing the degree of concordance between RC and NRC in treatment decision and management of SAHS patients
MATERIALS AND METHODS Study subjects The study population consisted of 88 consecutive subjects with a suspicion of SAHS age 5011 years 81 male BMI 304 Km2 from the out-patient clinics of three NRC in the Barcelona area Hospital Asil de Granollers Hospital General de Vic and Hospital de Terrassa
Study design The patients were evaluated independently at random over the course of 1 month in the RC and NRC In both types of centre the patient evaluation was carried out on the basis of the clinical history with a specific questionnaire about sleep disordered breathing and a sleep study in the hospital The evaluation was performed by a sleep physician in the RC and by a respiratory physician with training in sleep medicine in the NRC In both cases the choice of treatment was registered on an ordinal scale with four points 1 No diagnosis of SAHS and patient is discharged 2 Mild SAHS patient should follow a conservative treatment and clinical control 3 Moderate to severe SAHS patient should begin continuous positive air pressure CPAP treatment 4 Other sleep disorders are diagnosed RC or there is a need for full-night PSG owing to a discordance between clinical features and respiratory polygraphy in NRC The indication for CPAP treatment followed the national-SEPAR guidelines summarized as 1 Patients with severe SAHS-related symptoms with an AHI10 or 2 Patients with mild to moderate clinical symptoms with an AHI30 The human ethics committee of our hospital approved the protocol and informed consent was obtained from all the patients Sleep studies Reference hospital Full-night polysomnography was performed in the usual manner Briefly the variables registered were electroencephalogram chin electromyogram electro-oculogram tibial electromyogram arterial oxygen saturation ribcage and abdominal motion and their sum Airflow was measured by cannulathermistor An apnea was defined as the absence or airflow equal to or greater than 10 seconds Hypopnoea was defined by any discernible reduction in the amplitude of the airflow signal ending in an arousal andor association with a 3 desaturation with a duration of at least 10 seconds An expert technician scored sleep stages and respiratory variables manually An apnea-hypopnoea index AHI equal to or greater than 10 was considered abnormalNon-reference centres patients received a respiratory poligraphy with recording of body position ribcage and abdominal motion snoring arterial oxygen saturation and airflow using a cannulathermistor The respiratory physician performed a manual scoring of the recording The definitions of hypopnoea and apnea resembled those mentioned above except in the case of arousal Data analysis Data were entered using SPSS 100 and imported to STATA 70 to perform the analysis StatatCorp 1999 Stata Statistical software Release 70 College Station TX Stata Corporation Descriptive analysis Data were expressed as mean SD or percentage for quantitative and qualitative variables respectively For continuum variables a logarithmic transformation was undertaken to normalise the distribution if necessary If the distribution was not symmetrical data were expressed as percentiles Concordance analysis Evaluation of the concordance of the final outcome and the choice of treatment between the RF and the NFC centres was performed by using the statistic Kappa balanced penalizing extreme discrepancies following the classification of Landis Koch 25 This procedure was also used for the concordance in the result of the AHI of the sleep study categorised as follows 10 10-29 30 Concordance in the results of the sleep study AHI and CT90 was evaluated in accordance with the Band Altman methodology and the concordance coefficient of Lin
MATERIALS AND METHODS Study subjects The study population consisted of 88 consecutive subjects with a suspicion of SAHS age 5011 years 81 male BMI 304 Km2 from the out-patient clinics of three NRC in the Barcelona area Hospital Asil de Granollers Hospital General de Vic and Hospital de Terrassa
Study design The patients were evaluated independently at random over the course of 1 month in the RC and NRC In both types of centre the patient evaluation was carried out on the basis of the clinical history with a specific questionnaire about sleep disordered breathing and a sleep study in the hospital The evaluation was performed by a sleep physician in the RC and by a respiratory physician with training in sleep medicine in the NRC In both cases the choice of treatment was registered on an ordinal scale with four points 1 No diagnosis of SAHS and patient is discharged 2 Mild SAHS patient should follow a conservative treatment and clinical control 3 Moderate to severe SAHS patient should begin continuous positive air pressure CPAP treatment 4 Other sleep disorders are diagnosed RC or there is a need for full-night PSG owing to a discordance between clinical features and respiratory polygraphy in NRC The indication for CPAP treatment followed the national-SEPAR guidelines summarized as 1 Patients with severe SAHS-related symptoms with an AHI10 or 2 Patients with mild to moderate clinical symptoms with an AHI30 The human ethics committee of our hospital approved the protocol and informed consent was obtained from all the patients Sleep studies Reference hospital Full-night polysomnography was performed in the usual manner Briefly the variables registered were electroencephalogram chin electromyogram electro-oculogram tibial electromyogram arterial oxygen saturation ribcage and abdominal motion and their sum Airflow was measured by cannulathermistor An apnea was defined as the absence or airflow equal to or greater than 10 seconds Hypopnoea was defined by any discernible reduction in the amplitude of the airflow signal ending in an arousal andor association with a 3 desaturation with a duration of at least 10 seconds An expert technician scored sleep stages and respiratory variables manually An apnea-hypopnoea index AHI equal to or greater than 10 was considered abnormalNon-reference centres patients received a respiratory poligraphy with recording of body position ribcage and abdominal motion snoring arterial oxygen saturation and airflow using a cannulathermistor The respiratory physician performed a manual scoring of the recording The definitions of hypopnoea and apnea resembled those mentioned above except in the case of arousal Data analysis Data were entered using SPSS 100 and imported to STATA 70 to perform the analysis StatatCorp 1999 Stata Statistical software Release 70 College Station TX Stata Corporation Descriptive analysis Data were expressed as mean SD or percentage for quantitative and qualitative variables respectively For continuum variables a logarithmic transformation was undertaken to normalise the distribution if necessary If the distribution was not symmetrical data were expressed as percentiles Concordance analysis Evaluation of the concordance of the final outcome and the choice of treatment between the RF and the NFC centres was performed by using the statistic Kappa balanced penalizing extreme discrepancies following the classification of Landis Koch 25 This procedure was also used for the concordance in the result of the AHI of the sleep study categorised as follows 10 10-29 30 Concordance in the results of the sleep study AHI and CT90 was evaluated in accordance with the Band Altman methodology and the concordance coefficient of Lin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None