BiPAP Auto with BiFlex® as a rescue therapy for optimally treated obstructive sleep apnoea patients who demonstrate poor compliance to continuous positive airway pressure therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN88398555

Enrollment

Registered

2008-12-11

Start date

2006-08-21

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

After a full polysomnography (PSG) patients will be given a BiPAP Auto with Bi-Flex® device. Patients will be followed up at 15 days and 10 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female patients 18+ 2. Compliance to positive airway pressure (PAP) below the minimally acceptable level of 4 hours use on >=70% of nights over the past 4 weeks 3. Ability to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Wrong mask choice 2. Wrong mask size 3. Nasal congestion 4. Other symptoms requiring humidification

Design outcomes

Primary

Measure	Time frame
To determine whether rescuing optimally treated OSA patients who demonstrate poor compliance to PAP therapy by transitioning them onto BiPAP Auto with Bi-Flex improves compliance, subjective sleepiness and quality of life. 1. Compliance will be measured at 15 days and 10 weeks by retrieving device data 2. Subjective compliance and quality of life will be measured by Epworth Sleepiness Questionnaire and Functional Outcomes of Sleep Therapy questionnaire at baseline, 15 days and 10 weeks	—

Measure

Time frame

To determine whether rescuing optimally treated OSA patients who demonstrate poor compliance to PAP therapy by transitioning them onto BiPAP Auto with Bi-Flex improves compliance, subjective sleepiness and quality of life. 1. Compliance will be measured at 15 days and 10 weeks by retrieving device data 2. Subjective compliance and quality of life will be measured by Epworth Sleepiness Questionnaire and Functional Outcomes of Sleep Therapy questionnaire at baseline, 15 days and 10 weeks

—

Secondary

Measure	Time frame
1. Determination of comfort between BiPAP Auto with Bi-Flex® and previous device used. Measured by Device Comfort scale at baseline, 15 days and 10 weeks. 2. Identify barriers to successful transition onto BiPAP Auto with Bi-Flex®. Patients' previous machine type and mask will be noted and effect on transition assessed. 3. To determine the machine types used by patients who demonstrate poor compliance to fixed PAP therapy and their treatment efficacy during sleep. Previous machine type will be noted at baseline and treatment efficiency during baseline PSG. Tertiary objective: 4. To investigate the level of agreement between Apnoea-Hypopnea Index (AHI) measured at Visit 1 (15 days) by PSG and an autotitrating PAP device in a subgroup of patients. Carried out at Visit 1 by PSG.	—

Measure

Time frame

1. Determination of comfort between BiPAP Auto with Bi-Flex® and previous device used. Measured by Device Comfort scale at baseline, 15 days and 10 weeks. 2. Identify barriers to successful transition onto BiPAP Auto with Bi-Flex®. Patients' previous machine type and mask will be noted and effect on transition assessed. 3. To determine the machine types used by patients who demonstrate poor compliance to fixed PAP therapy and their treatment efficacy during sleep. Previous machine type will be noted at baseline and treatment efficiency during baseline PSG. Tertiary objective: 4. To investigate the level of agreement between Apnoea-Hypopnea Index (AHI) measured at Visit 1 (15 days) by PSG and an autotitrating PAP device in a subgroup of patients. Carried out at Visit 1 by PSG.

—

Countries

France

Outcome results

None listed

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