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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Catalonia
-
Lleida, Catalonia, Spanien, 25198
- Hospital Santa Maria
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Kein Eingriff: 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.
|
|
|
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.
|
The study evaluates two different setting to follow up patients with obstructive sleep apnea on CPAP treatment
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of hours of use per day of CPAP
Zeitfenster: Six month
|
Number of hours of use per day of CPAP according to the internal clock of the CPAP device
|
Six month
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Daytime sleepiness
Zeitfenster: At baseline and at 6 month of follow-up
|
Epworth Sleepiness Scale (ESS)
|
At baseline and at 6 month of follow-up
|
|
Patient satisfaction
Zeitfenster: Six month
|
visual analog scale (0-10)
|
Six month
|
|
Adverse events
Zeitfenster: Six month
|
Adverse events related to CPAP treatment
|
Six month
|
|
Quality of life
Zeitfenster: Baseline and at 6 month of follow up
|
EuroQol
|
Baseline and at 6 month of follow up
|
|
Cost-efficacy evaluation
Zeitfenster: Six month
|
Qualys
|
Six month
|
|
Comorbidity index
Zeitfenster: Six month
|
Charlson index
|
Six month
|
|
Blood pressure
Zeitfenster: Sixt month
|
Office blood pressure
|
Sixt month
|
|
Lost of follow up
Zeitfenster: Six month
|
Percentage of patients lost during follow up
|
Six month
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Body mass index
Zeitfenster: Six month
|
Six month
|
Mitarbeiter und Ermittler
Ermittler
- Studienleiter: Ferran Barbe, MD, Hospital Anrnau Vilanova- Santa Maria, Lleida (Spain)
- Hauptermittler: Cristina Esquinas, RN, MPH, Hospital Arnau Vilanova-Santa Maria, Lleida (Spain)
- Hauptermittler: Nuria Nadal, MD, Primary Care. National Health Institute. Lleida (Spain)
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- PI12/01499
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur OSA
-
Brigham and Women's HospitalRekrutierungOSAVereinigte Staaten
-
Biocubica srlAbgeschlossen
-
Hospital Clinic of BarcelonaAbgeschlossen
-
Brigham and Women's HospitalRekrutierungOSAVereinigte Staaten
-
Woolcock Institute of Medical ResearchFullpower Technologies, Inc.Rekrutierung
-
Mahidol UniversityUnbekanntOSA | KomplikationThailand
-
Chang Gung Memorial HospitalUnbekannt
-
Changi General HospitalAbgeschlossen
-
Mayo ClinicAnmeldung auf EinladungObstruktive Schlafapnoe | OSA | Obstruktive Schlafapnoe (OSA)Vereinigte Staaten