Usefulness of Reinforcing Interventions on CPAP Compliance
Forty consecutive patients (27 male and 13 female) older than 18 years, with diagnosis of OSA and indication to CPAP treatment, according to international guidelines, were recruited by the sleep disordered breathing Centre of IBIM-CNR Palermo. The total number of 40 patients was chosen a priori. The protocol was approved by the local ethical committee (Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell'Università degli Studi di Palermo) and all persons gave their written informed consent prior to their inclusion in the study. Patients with impairments or comorbidities considered likely to interfere with adherence to instructions were excluded: neuromuscular disease, unstable psychiatric disease or cognitive impairment considered likely to interfere with adherence to instructions, myocardial infarction, unstable angina, cardiac failure, cerebrovascular accident, lung disease with awake resting oxygen saturation of less than 90%.
Nocturnal cardiorespiratory recording (Somté or Somnea Compumedics, Abbotsford, Australia) was performed for diagnosis of OSA. On the cardiorespiratory recordings, time between estimated first sleep onset and last morning awakening was analyzed. Apneas and hypopneas were manually analyzed. Apneas were identified on the airflow signal, and were classified as obstructive, central, or mixed, according to behaviour of thoraco-abdominal movements. Hypopneas were scored when a ≥30% reduction in the airflow signal was detected in association with a reduction ≥4% of oxyhemoglobin saturation (SaO2). Apnea/hypopnea index (AHI) was calculated as the number of (apneas + hypopneas)/h of recording that was analyzed. Time with SaO2 below 90% (TSat ≤90%) was calculated.
Before CPAP titration, all patients were informed by the medical personnel about the diagnosis with a description of the disease and the consequences of ineffective treatment, and about the follow-up. Then, the nursing staff identified the suitable mask and held a morning session of education and training to the CPAP therapy. The duration of this phase was about 30 minutes. In lab CPAP titration was performed with the AutoSet (ResMed Abingdon UK) auto-titrating CPAP device with full nocturnal polysomnography. Throughout the night and the next morning, the nurses on duty dealt with any discomfort related to the CPAP treatment. Fixed CPAP was prescribed to each patient at the pressure needed to abolish obstructive respiratory events, airflow limitation and snoring, as determined by the overnight AutoSet CPAP titration study. The same CPAP machine was given to every patient (Weinmann SOMNOcomfort 2e) and all subjects were advised to use their CPAP machine as often as possible when asleep. Then patients were randomised to receive extra early support (intervention group) or standard follow-up (control group).
After receiving the CPAP device, all patients were provided with a telephone number to call the doctor of the sleep centre for support within office hours. The home care provider visited all patients at their home at month 3, 6, 12 from the start of therapy, and each time he downloaded data from the device memory (time of device use per night), controlled BMI, administered Epworth Sleepiness Scale (ESS), and transmitted all data to the sleep centre that analyzed them. In the intervention group ESS was administered also the 30th day from the beginning of the therapy.
Patients in the intervention group received a standardized daily telephone interview from their sleep doctor on the first week of therapy and at one month after therapy start. During the interview they were asked about the most common adverse events during CPAP treatment: i.e. abrasions or rashes, nasal pain, conjunctivitis from air leakage, bloating, sinusitis and rhinitis, difficulty in breathing out, sense of chest tightness, dryness of the nose and mouth, nosebleeds. The doctor reviewed progress and gave advice to manage CPAP-related adverse effects, and encouraged to maintain adherence to therapy. Besides, when necessary, technical support was given by the home care provider. The protocol is shown in Figure 1.
(Enlarge Image)
Figure 1.
Flow-diagram showing the path of the proposed support. OSAS, obstructive sleep apnea syndrome; CPAP, continuous positive airway pressure; BMI, body mass index; ESS, Epworth Sleepiness Score.
The effect of the support on CPAP adherence, defined as the monthly average number of days of therapy ≥4 hours, was evaluated by non parametric Wilcoxon/Kruskal-Wallis test. Data were reported as mean ± SD. A p <0.05 was considered significant. Statistical analysis was performed by commercial software (JMP 8.0 SAS Institute Inc.).
Methods
Forty consecutive patients (27 male and 13 female) older than 18 years, with diagnosis of OSA and indication to CPAP treatment, according to international guidelines, were recruited by the sleep disordered breathing Centre of IBIM-CNR Palermo. The total number of 40 patients was chosen a priori. The protocol was approved by the local ethical committee (Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell'Università degli Studi di Palermo) and all persons gave their written informed consent prior to their inclusion in the study. Patients with impairments or comorbidities considered likely to interfere with adherence to instructions were excluded: neuromuscular disease, unstable psychiatric disease or cognitive impairment considered likely to interfere with adherence to instructions, myocardial infarction, unstable angina, cardiac failure, cerebrovascular accident, lung disease with awake resting oxygen saturation of less than 90%.
Nocturnal cardiorespiratory recording (Somté or Somnea Compumedics, Abbotsford, Australia) was performed for diagnosis of OSA. On the cardiorespiratory recordings, time between estimated first sleep onset and last morning awakening was analyzed. Apneas and hypopneas were manually analyzed. Apneas were identified on the airflow signal, and were classified as obstructive, central, or mixed, according to behaviour of thoraco-abdominal movements. Hypopneas were scored when a ≥30% reduction in the airflow signal was detected in association with a reduction ≥4% of oxyhemoglobin saturation (SaO2). Apnea/hypopnea index (AHI) was calculated as the number of (apneas + hypopneas)/h of recording that was analyzed. Time with SaO2 below 90% (TSat ≤90%) was calculated.
Before CPAP titration, all patients were informed by the medical personnel about the diagnosis with a description of the disease and the consequences of ineffective treatment, and about the follow-up. Then, the nursing staff identified the suitable mask and held a morning session of education and training to the CPAP therapy. The duration of this phase was about 30 minutes. In lab CPAP titration was performed with the AutoSet (ResMed Abingdon UK) auto-titrating CPAP device with full nocturnal polysomnography. Throughout the night and the next morning, the nurses on duty dealt with any discomfort related to the CPAP treatment. Fixed CPAP was prescribed to each patient at the pressure needed to abolish obstructive respiratory events, airflow limitation and snoring, as determined by the overnight AutoSet CPAP titration study. The same CPAP machine was given to every patient (Weinmann SOMNOcomfort 2e) and all subjects were advised to use their CPAP machine as often as possible when asleep. Then patients were randomised to receive extra early support (intervention group) or standard follow-up (control group).
After receiving the CPAP device, all patients were provided with a telephone number to call the doctor of the sleep centre for support within office hours. The home care provider visited all patients at their home at month 3, 6, 12 from the start of therapy, and each time he downloaded data from the device memory (time of device use per night), controlled BMI, administered Epworth Sleepiness Scale (ESS), and transmitted all data to the sleep centre that analyzed them. In the intervention group ESS was administered also the 30th day from the beginning of the therapy.
Patients in the intervention group received a standardized daily telephone interview from their sleep doctor on the first week of therapy and at one month after therapy start. During the interview they were asked about the most common adverse events during CPAP treatment: i.e. abrasions or rashes, nasal pain, conjunctivitis from air leakage, bloating, sinusitis and rhinitis, difficulty in breathing out, sense of chest tightness, dryness of the nose and mouth, nosebleeds. The doctor reviewed progress and gave advice to manage CPAP-related adverse effects, and encouraged to maintain adherence to therapy. Besides, when necessary, technical support was given by the home care provider. The protocol is shown in Figure 1.
(Enlarge Image)
Figure 1.
Flow-diagram showing the path of the proposed support. OSAS, obstructive sleep apnea syndrome; CPAP, continuous positive airway pressure; BMI, body mass index; ESS, Epworth Sleepiness Score.
Statistical Analysis
The effect of the support on CPAP adherence, defined as the monthly average number of days of therapy ≥4 hours, was evaluated by non parametric Wilcoxon/Kruskal-Wallis test. Data were reported as mean ± SD. A p <0.05 was considered significant. Statistical analysis was performed by commercial software (JMP 8.0 SAS Institute Inc.).
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