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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN93709209

Enrollment

Registered

2008-05-15

Start date

2007-08-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive sleep apnoea Nervous System Diseases Sleep disorders

Interventions

A-Flex: automatic positive airways pressure device featuring pressure relief technology APAP: standard automatic positive airways pressure device The duration of treatment and follow up during the fi

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. A-Flex is more comfortable than APAP, measured using the Visual Analogue Scale [VAS] at baseline 2. Compliance (internal clock within the device) is higher on A-Flex compared to APAP, measured at one and three months 3. Subjective daytime sleepiness is improved on A-Flex compared to APAP, measured using the Epworth Sleepiness Scale at baseline, one and three months 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	—

Measure

Time frame

1. A-Flex is more comfortable than APAP, measured using the Visual Analogue Scale [VAS] at baseline 2. Compliance (internal clock within the device) is higher on A-Flex compared to APAP, measured at one and three months 3. Subjective daytime sleepiness is improved on A-Flex compared to APAP, measured using the Epworth Sleepiness Scale at baseline, one and three months 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

—

Countries

France, Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026