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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Catalonia
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Lleida, Catalonia, Espagne, 25198
- Hospital Santa Maria
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of hours of use per day of CPAP
Délai: Six month
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Number of hours of use per day of CPAP according to the internal clock of the CPAP device
|
Six month
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Daytime sleepiness
Délai: At baseline and at 6 month of follow-up
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Epworth Sleepiness Scale (ESS)
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At baseline and at 6 month of follow-up
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Patient satisfaction
Délai: Six month
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visual analog scale (0-10)
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Six month
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Adverse events
Délai: Six month
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Adverse events related to CPAP treatment
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Six month
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Quality of life
Délai: Baseline and at 6 month of follow up
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EuroQol
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Baseline and at 6 month of follow up
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Cost-efficacy evaluation
Délai: Six month
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Qualys
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Six month
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Comorbidity index
Délai: Six month
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Charlson index
|
Six month
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Blood pressure
Délai: Sixt month
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Office blood pressure
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Sixt month
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Lost of follow up
Délai: Six month
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Percentage of patients lost during follow up
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Six month
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Autres mesures de résultats
Mesure des résultats |
Délai |
|---|---|
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Body mass index
Délai: Six month
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Six month
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Collaborateurs et enquêteurs
Les enquêteurs
- Directeur d'études: Ferran Barbe, MD, Hospital Anrnau Vilanova- Santa Maria, Lleida (Spain)
- Chercheur principal: Cristina Esquinas, RN, MPH, Hospital Arnau Vilanova-Santa Maria, Lleida (Spain)
- Chercheur principal: Nuria Nadal, MD, Primary Care. National Health Institute. Lleida (Spain)
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- PI12/01499
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