Management of Patients With Suspected of Sleep Apnea-hypopnea Syndrome From Primary Care

NCT02234765 | Completed

• 1 other identifier: PI13/02004
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea syndrome (OSA) is characterized by the manifestation of excessive sleepiness secondary to repeated obstruction of the upper airway during sleep and cognitive-behavioral, respiratory, cardiac, metabolic or inflammatory disorders. Epidemiological studies in our country have shown that OSA is a highly prevalent disease in the general population, affecting 2-4% of the adult population. The most important clinical manifestations of OSAS is a deterioration in the quality of life and an increase in cardiovascular disease. OSA is also associated with traffic accidents. Therefore, and considering the medical complications of OSA, as well as the sociolaboral impact and its negative impact on quality of life and survival; is stated that this disease is a public health problem that requires the physician to identify patients eligible to treatment. Moreover, it has been shown that undiagnosed patients, duplicate the consumption of health resources, comparing when the diagnosis and treatment has been established. Finally, we have a highly effective treatment using positive pressure in the upper airway (CPAP) that has been shown to be effective and cost-effective. The current situation in which all patients diagnosed with OSA and receiving different treatments are monitored and controlled by the Sleep Units (SU) is an oversized medicine specialist at the expense of primary care (PC). Our working hypothesis is: "By the coordination of actions at various levels including interactive training equipment AP, use the bilateral (SU-AP) of electronic medical records and the use of new technologies can be achieved in AP satisfactory management of the diagnostic and therapeutic process of patients with suspected OSA. Patients assisted in both areas have a level of clinical response, satisfaction, compliance and avoidance of complications, similar to that obtained with monitoring by SU. In addition, management by AP will be more cost-effective than in the SU."

Conditions

Sleep Apnea Syndrome

Keywords

OSA; OSAS; Sleep apnea; Management; Primary Care; Sleep Unit; Cost-Effectiveness; ESS

Outcome Measures

Primary Outcomes (2)

• Change from baseline in daytime sleepiness (ESS score) at 6 months

  Epworth Sleepiness Scale (ESS)

  baseline and 6 months

• Cost-effectiveness at 6 months

  QUALYS

  6 months

Secondary Outcomes (7)

• Change from baseline in quality of life

  baseline and 6 months

• Satisfaction at 6 months

  6 months

• CPAP compliance at 6 months

  6 months

• Adverse events at 6 months

  6 months

• Change from baseline in blood pressure

  Baseline and 6 months

Study Arms (2)

Sleep Unit

ACTIVE COMPARATOR

Patients diagnosed and followed up in the Sleep Unit.

Other: Standard management

Primary Care

EXPERIMENTAL

Patients diagnosed and followed up in the Primary Care.

Other: Primary Care-based management

Interventions

Primary Care-based management OTHER

Patients will be diagnosed and follow-up in Primary Care.

Primary Care

Standard management OTHER

Standard management according to Spanish Respiratory Society guidelines in Sleep Unit.

Sleep Unit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women over 18 years old
• Suspected OSA patients (chronic snoring, apneas, excessive daytime sleepiness) or resistant hypertension
• Written informed consent signed

You may not qualify if:

• Patients with impaired lung function (sd. overlap, obesity hypoventilation, and restrictive disorders)
• Severe heart failure
• Severe chronic pathology associated
• Psychiatric disorder
• Periodic leg movements
• Pregnancy
• Other dyssomnias or parasomnias
• Patients already treated with CPAP

Sponsors & Collaborators

• Sociedad Española de Neumología y Cirugía Torácica: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Hospital Arnau de Vilanova-Santa María

Lleida, Lleida, 25198, Spain

Location

Related Publications (1)

• Tarraubella N, Sanchez-de-la-Torre M, Nadal N, De Batlle J, Benitez I, Cortijo A, Urgeles MC, Sanchez V, Lorente I, Lavega MM, Fuentes A, Clotet J, Llort L, Vilo L, Juni MC, Juarez A, Gracia M, Castro-Grattoni AL, Pascual L, Minguez O, Masa JF, Barbe F. Management of obstructive sleep apnoea in a primary care vs sleep unit setting: a randomised controlled trial. Thorax. 2018 Dec;73(12):1152-1160. doi: 10.1136/thoraxjnl-2017-211237. Epub 2018 Jul 31.

  PMID: 30064993 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Ferran Barbe, MD

  Hospital Arnau de Vilanova. IRB Lleida. CIBERes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 9, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: May 1, 2016
• Last Updated: February 14, 2017

Record last verified: 2017-02

Locations

ES (1)