Follow-up of Patients With Obstructive Sleep Apnea in Primary Care.
Follow-up of Patients With the Apnea-hypopnea Syndrome in Primary Care and Sleep Disorders Units. Equivalence Randomized Comparative Study on Compliance and Clinical Response.
The objective of the study is to compare the results of a coordinated and interactive program for the treatment, monitoring and control of patients with a moderate-severe diagnosis of Obstructive Sleep Apnea (OSA) and treated with positive continuous pressure (CPAP), with the currently established situation.
Methodology: Equivalence randomized comparative study . It will include patients with diagnosis of moderate-severe OSA (apnea-hypopnea Index >=15) that should start treatment with (CPAP). Participating center is Hospital Santa María-Arnau de Vilanova in Lleida (Spain).These patients will be randomized to two monitoring groups (1: monitoring in the Sleep disorders unit, 2: monitoring in primary care consultations) once the OSAS diagnosis has been made and it was indicated that treatment with CPAP. Patients Will be carried out in both groups the same follow-up visits in two study arms: basal, 1 month, 3 months and 6 months. Primary outcomes: number of hours of use per day (according to the accountant of the CPAP), so that use >= 4h/day is defined as good adherence to the treatment. Secondary outcomes: daytime sleepiness, patient satisfaction, Adverse events related to CPAP treatment. It will be collected demographic ,clinics and anthropometric variables. At the end of follow-up primary and secondary outcomes will be compared between two groups.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Catalonia
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Lleida, Catalonia, Espanha, 25198
- Hospital Santa Maria
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Men and women over 18 years old.
- Patients with OSA diagnosis performed in the sleep units
- Written informed consent signed.
Exclusion Criteria:
- Previous CPAP treatment for OSA diagnosis
- Psycho-physical inability to complete questionnaires.
- Presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivation, regular use of hypnotic or sedative medications and restless leg syndrome
- Patients with respiratory diseases (overlap syndrome, hypoventilation, restrictive diseases)
- A medical history that may interfere with the study objectives or, in the opinion of the investigator, compromise the conclusions.
- Any medical factor, social or geographical, that may jeopardize patient compliance.(e.g., alcohol consumption (more 80 gr/day in men and more than 60 gr / day in women), no fixed address, disorientation, or a history of non-compliance).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: Sleep Unit group
This group will have standard follow up in sleep unit at 1, 3 and 6 month.
These patients will also be instructed in hygienic-dietary measures, standard care of cardiovascular risk factors and sleep hygiene counseling.
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Experimental: Primary Care group
This group will have standard follow up in primary care at 1, 3 and 6 month.
These patients will also be instructed in hygienic-dietary measures, standard care of cardiovascular risk factors and sleep hygiene counseling.
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The study evaluates two different setting to follow up patients with obstructive sleep apnea on CPAP treatment
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of hours of use per day of CPAP
Prazo: Six month
|
Number of hours of use per day of CPAP according to the internal clock of the CPAP device
|
Six month
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Daytime sleepiness
Prazo: At baseline and at 6 month of follow-up
|
Epworth Sleepiness Scale (ESS)
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At baseline and at 6 month of follow-up
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Patient satisfaction
Prazo: Six month
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visual analog scale (0-10)
|
Six month
|
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Adverse events
Prazo: Six month
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Adverse events related to CPAP treatment
|
Six month
|
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Quality of life
Prazo: Baseline and at 6 month of follow up
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EuroQol
|
Baseline and at 6 month of follow up
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Cost-efficacy evaluation
Prazo: Six month
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Qualys
|
Six month
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Comorbidity index
Prazo: Six month
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Charlson index
|
Six month
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Blood pressure
Prazo: Sixt month
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Office blood pressure
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Sixt month
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Lost of follow up
Prazo: Six month
|
Percentage of patients lost during follow up
|
Six month
|
Outras medidas de resultado
Medida de resultado |
Prazo |
|---|---|
|
Body mass index
Prazo: Six month
|
Six month
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Ferran Barbe, MD, Hospital Anrnau Vilanova- Santa Maria, Lleida (Spain)
- Investigador principal: Cristina Esquinas, RN, MPH, Hospital Arnau Vilanova-Santa Maria, Lleida (Spain)
- Investigador principal: Nuria Nadal, MD, Primary Care. National Health Institute. Lleida (Spain)
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- PI12/01499
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