Home Nasal Pressure for Sleep Apnea Management in Primary Case

Sociedad Española de Neumología y Cirugía Torácica

Status: Completed

Conditions: Obstructive Sleep Apnea Syndrome

Treatments: Device: Diagnosis, autoCPAP, follow up.

Study type: Interventional

Funder types: Other

Identifiers

NCT02141165

PI13/0238

Details and patient eligibility

About

Primary objectives: To determine the efficacy and cost-effectiveness of a management program for patients with obstructive sleep apnea syndrome (OSAS) carried out in primary or specialist healthcare. In the primary arm, the diagnosis and therapeutic decision will be made by means of a domiciliary nasal pressure (DNP) channel and oximetry while the specialist healthcare arm will use polysomnography (PSG) in a hospital. Patients with an intermediate-high suspicion of OSAS will be included, taking as primary variables the Epworth scale, for efficacy, and the Epworth scale and EuroQol 5D, for cost-effectiveness.

Secondary objectives: efficacy of the two SAHS management programs according to the following secondary variables: a) quality-of-life tests: FOSQ questionnaire, SF36 and analogical wellbeing scale, b) adherence to and compliance with the treatment.

Full description

Design: prospective, randomized, controlled, open, parallel, non-inferiority. A total of 280 patients will be randomized for management on the basis of DNP (primary) or PSG (specialist), thereby giving rise to 4 groups: two treated and two not treated with CPAP. The former will undergo a home auto-titration. The follow-up will last 6 months and include 4 evaluations.

Enrollment: 280 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Snoring or apneas objectively observed during sleep by a partner;
2. Symptoms that are potentially secondary to apneas/hypopneas with an intermediate-high probability of being treated with CPAP. In operative terms, Epworth scale ≥12 or previous cardiovascular disease;
3. Age between 18 and 70 years;
4. Absence of any clinical suspicion of any other sleep pathology susceptible to coinciding with daytime sleepiness.

Exclusion criteria

1. Psycho-physical incapacity to complete questionnaires;
2. Documented structural or coronary heart disease uncontrolled by any medical treatment;
3. Cheyne-Stokes syndrome;
4. Patients subjected to uvulopalatopharyngoplasty;
5. Significant nasal obstruction impeding the use of CPAP;
6. Pregnancy;
7. Lack of informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

Primary.

Experimental group

Description:

Diagnosis, autoCPAP, follow up.

Treatment:

Device: Diagnosis, autoCPAP, follow up.

Hospital

Active Comparator group

Description:

Diagnosis, autoCPAP, follow up

Treatment:

Device: Diagnosis, autoCPAP, follow up.