Home Nasal Pressure for Sleep Apnea Management in Primary Case

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Primary.

Diagnosis, autoCPAP, follow up.

Group Type EXPERIMENTAL

Diagnosis, autoCPAP, follow up.

Intervention Type DEVICE

comparison between the efficacy of two protocol

Hospital

Diagnosis, autoCPAP, follow up

Group Type ACTIVE_COMPARATOR

Diagnosis, autoCPAP, follow up.

Intervention Type DEVICE

comparison between the efficacy of two protocol

Interventions

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Diagnosis, autoCPAP, follow up.

comparison between the efficacy of two protocol

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No