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

ISRCTN	ISRCTN59353477
DOI	https://doi.org/10.1186/ISRCTN59353477
Secondary identifying numbers	N/A

Submission date: 29/09/2008
Registration date: 20/11/2008
Last edited: 20/11/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof J Meurice
Scientific

Service de Pneumologie
Cité Hospitalière La Milétrie
BP 577
Poitiers
86021
France

Email	meurice@chu-poitiers.fr

Study information

Study design	Randomised crossover trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact etails below to request a copy of the information sheet
Scientific title
Study objectives	REMstar® Auto with C-FLEX is as effective at reducing the apnoea-hypopnoea index (AHI) in sleep apnoea/ hypopnoea patients as continuous positive airway pressure over 30 days when used in the home environment.
Ethics approval(s)	Research Ethics Committee for Protection of Human Subjects, Poitou-Charentes (Comite Consultatif de Protection des Personnes dans la Recherche, Biomedicale de la region Poitou-Charentes), approved on 20/10/ 2005 (ref: 05.09.17)
Health condition(s) or problem(s) studied	Sleep apnoea/ hypopnoea syndrome
Intervention	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 by a 7-day washout period, and then the participants were crossed over to 30 days on alternate arm of study.
Intervention type	Other
Primary outcome measure	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 outcome measures	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
Overall study start date	06/10/2005
Completion date	13/03/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target number of participants	20
Key inclusion criteria	1. Male adults >18 2. Index of apnoea/ hypopnoeas >30/hour 3. Able to provide written consent
Key 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
Date of first enrolment	06/10/2005
Date of final enrolment	13/03/2008

Locations

Countries of recruitment

France

Study participating centre

Service de Pneumologie

Poitiers
86021
France

Sponsor information

Respironics International (France)
Industry

20 Rue-Jacques Daguerre
Rueil-Malmaison
Paris
92500
France

Email	steven.coughlin@respironics.com
Website	http://global.respironics.com
"ROR"	https://ror.org/05jz46060

Funders

Funder type

Industry

Respironics International (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan