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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Catalonia
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Lleida, Catalonia, Spania, 25198
- Hospital Santa Maria
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of hours of use per day of CPAP
Tidsramme: Six month
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Number of hours of use per day of CPAP according to the internal clock of the CPAP device
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Six month
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Daytime sleepiness
Tidsramme: 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
Tidsramme: Six month
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visual analog scale (0-10)
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Six month
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Adverse events
Tidsramme: 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
Tidsramme: 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
Tidsramme: Six month
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Qualys
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Six month
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Comorbidity index
Tidsramme: Six month
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Charlson index
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Six month
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Blood pressure
Tidsramme: Sixt month
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Office blood pressure
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Sixt month
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Lost of follow up
Tidsramme: Six month
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Percentage of patients lost during follow up
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Six month
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Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Body mass index
Tidsramme: Six month
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Six month
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Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Ferran Barbe, MD, Hospital Anrnau Vilanova- Santa Maria, Lleida (Spain)
- Hovedetterforsker: Cristina Esquinas, RN, MPH, Hospital Arnau Vilanova-Santa Maria, Lleida (Spain)
- Hovedetterforsker: Nuria Nadal, MD, Primary Care. National Health Institute. Lleida (Spain)
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- PI12/01499
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