Home Nasal Pressure for Sleep Apnea Management in Primary Case

Obstructive Sleep Apnea Syndrome Clinical Trial

— Primary  

Official title:

Efficacy and Cost-Effectiveness of a Super Simplified System for the Management of Patients With Sleep Apneas in Primary Healthcare.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02141165
• Other study ID #: PI13/0238
• Status: Completed
• Phase: N/A
• First received: February 17, 2014
• Last updated: March 14, 2017
• Start date: March 2014
• Est. completion date: March 2017

Study information

• Verified date: January 2017
• Source: Sociedad Española de Neumología y Cirugía Torácica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: March 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Diagnosis, autoCPAP, follow up.
comparison between the efficacy of two protocol

Locations

Country	Name	City	State
Spain	Juan Fernando Masa Jiménez	Cáceres

Sponsors (1)

Lead Sponsor	Collaborator
Sociedad Española de Neumología y Cirugía Torácica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of the extra- and intra-hospital programs using DNP or PSG, taking as primary variable the Epworth scale.		Before and after 6 months of follow-up
Secondary	Cost-effectiveness of the exta- and intra-hospital management programs using DNP or PSG, evaluated by means of the Epworth scale and EuroQol 5D.		Before and after 6 months of follow-up