Therapy-efficacy of automatic positive airways pressure therapy with A-Flex compared to standard automatic positive airways pressure therapy in obstructive sleep apnoea (OSA) patients

Completed

Conditions: Obstructive sleep apnoea
Nervous System Diseases
Sleep disorders

Registration Number: ISRCTN93709209

Lead Sponsor: Respironics International Inc. (France)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

1. Apnoea-Hypopnoea Index (AHI) greater than 15/h confirmed by full polysomnograph (PSG)
2. Aged greater than or equal to 21 to less than or equal to 65 years, either sex
3. Body mass index (BMI) less than 40 kg/m^2
4. Able to follow the study protocol

Exclusion Criteria

1. Acute upper respiratory infection, encephalitis, sinusitis or middle ear infection
2. Drug abuse
3. Intake of central relevant drugs, sedatives, or other drugs which impair sleep
4. Alcohol abuse
5. Psychiatric or neurological diseases resulting in impairment of sleep, therapy or compliance
6. Thyroidal dysfunction
7. Chronic pain syndromes
8. Acute cardiac, pulmonary, and other internal diseases
9. Chronic cardiac, pulmonary and other internal diseases resulting in impairment of sleep
10. Central sleep related breathing disorders or other disorders resulting in hypoventilation
11. Periodic leg movements (PLM)/restless legs syndrome (RLS)
12. Previous exposure to either continuous positive airways pressure (CPAP) or bi-level therapy
13. Patients experiencing acute dermatitis or other skin lesions or trauma interfering with the application of a mask
14. Participation in another clinical study in the past four weeks

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A-Flex is as effective as APAP in reducing respiratory events and arousals in patients with OSA, measured with the Apnoea-Hypopnea Index at baseline.

Secondary Outcome Measures

Name	Time	Method
1. A-Flex is more comfortable than APAP, measured using the Visual Analogue Scale [VAS] at baseline<br>2. Compliance (internal clock within the device) is higher on A-Flex compared to APAP, measured at one and three months<br>3. Subjective daytime sleepiness is improved on A-Flex compared to APAP, measured using the Epworth Sleepiness Scale at baseline, one and three months<br>4. Quality of life is improved on A-Flex compared to APAP, measured using the Functional Outcomes of Sleep Questionnaire at baseline, one and three months