Treatment by uninterrupted positive airway pressure by nasal route - Evaluation of REMstar® Auto with C-Flex in clinical practice

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN59353477

Enrollment

Registered

2008-11-20

Start date

2005-10-06

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

Sleep apnoea/ hypopnoea syndrome Nervous System Diseases Sleep disorders

Interventions

Participants were randomly allocated to the following two arms: Arm 1: REMstar® Auto with C-FLEX over 30 days Arm 2: Continuous positive airway pressure over 30 days The intervention was followed

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Male adults >18 2. Index of apnoea/ hypopnoeas >30/hour 3. Able to provide written consent

Exclusion criteria

Exclusion criteria: 1. Past experience of treatment with positive airway pressure or non invasive ventilation 2. Participants who require 2 levels of pressure for nocturnal alveolar hypoventilation linked to a co-morbidity (obesity, hypoventilation, chronic obstructive pulmonary disease [COPD]) of sleep aponea/ hypopnoea syndrome 3. Participants that have undergone surgery for the treatment of sleep apnoea/ hypopnoea syndrome, snore or tumour in the last 6 months or after their polysomnography (PSG) diagnosis 4. Tracheostomy 5. Respiratory infection, sinusitis or internal ear infection 6. Dermatitis or other facial lesions preventing the application of a mask 7. Unable to give written informed consent 8. Participants unwilling to volunteer 9. Unstable medication 10. Participants presenting with clinically significant COPD or unstable cardiac insufficiency 11. People benefiting from a reinforced protection will not be included in this study. This refers to subjects protected by law, persons accepted in a health or social establishment, private individuals of freedom by a court or administrative order, ill in urgent situation, and persons hospitalised without consent. 12. Participants should not have participated in a trial in the 3 months preceding or following the study

Design outcomes

Primary

Measure	Time frame
1. To determine if the REMstar® Auto in C-Flex mode is as effective as constant positive airway pressure on reducing the AHI of sleep apnoea/ hypopnea patients when used in the home environment. This will be assessed by data obtained during polygraph recording via the Stardust® device at the beginning and end of each period (30 days, 7-day washout then 30 days on alternate arm of study) and between each mode of use. This relates primarily to the following: a. AHI index b. Sa02 night (minimum, maximum and Sa02 95) 2. Data from the REMstar® device at the beginning and end of each period and between each mode of use. This relates primarily to the following: a. Maximum pressure b. Minimum pressure c. Average pressure d. Average number of hours use on nights used e. AHI index	—

Measure

Time frame

1. To determine if the REMstar® Auto in C-Flex mode is as effective as constant positive airway pressure on reducing the AHI of sleep apnoea/ hypopnea patients when used in the home environment. This will be assessed by data obtained during polygraph recording via the Stardust® device at the beginning and end of each period (30 days, 7-day washout then 30 days on alternate arm of study) and between each mode of use. This relates primarily to the following: a. AHI index b. Sa02 night (minimum, maximum and Sa02 95) 2. Data from the REMstar® device at the beginning and end of each period and between each mode of use. This relates primarily to the following: a. Maximum pressure b. Minimum pressure c. Average pressure d. Average number of hours use on nights used e. AHI index

—

Secondary

Measure	Time frame
1. To compare the clinical benefits and preference of patients between the REMstar® Auto in C-Flex mode versus conventional fixed pressure. This will be assessed at the beginning and end of each period and between each mode of use. 2. Quality of life and daytime alertness will be assessed by the Functional Outcome of Sleep Questionnaire (FOSQ) and the Epworth Sleepiness Questionnaire (ESS). Timepoints: Baseline (before first mode of use), after first mode of use is completed and after the second mode of use is completed. 3. A visual analogue scale will be completed by the participants at the end of each treatment period to assess daytime alertness	—

Measure

Time frame

1. To compare the clinical benefits and preference of patients between the REMstar® Auto in C-Flex mode versus conventional fixed pressure. This will be assessed at the beginning and end of each period and between each mode of use. 2. Quality of life and daytime alertness will be assessed by the Functional Outcome of Sleep Questionnaire (FOSQ) and the Epworth Sleepiness Questionnaire (ESS). Timepoints: Baseline (before first mode of use), after first mode of use is completed and after the second mode of use is completed. 3. A visual analogue scale will be completed by the participants at the end of each treatment period to assess daytime alertness

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Countries

France

Outcome results

None listed

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