Condition category
Nervous System Diseases
Date applied
29/09/2008
Date assigned
20/11/2008
Last edited
20/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof J Meurice

ORCID ID

Contact details

Service de Pneumologie
Cité Hospitalière La Milétrie
BP 577
Poitiers
86021
France
meurice@chu-poitiers.fr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

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)

Study design

Randomised crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact etails below to request a copy of the information sheet

Condition

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

Phase

Phase IV

Drug names

Primary outcome measures

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 trial start date

06/10/2005

Overall trial end date

13/03/2008

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

20

Participant 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

Recruitment start date

06/10/2005

Recruitment end date

13/03/2008

Locations

Countries of recruitment

France

Trial participating centre

Service de Pneumologie
Poitiers
86021
France

Sponsor information

Organisation

Respironics International (France)

Sponsor details

20 Rue-Jacques Daguerre
Rueil-Malmaison
Paris
92500
France
steven.coughlin@respironics.com

Sponsor type

Industry

Website

http://global.respironics.com

Funders

Funder type

Industry

Funder name

Respironics International (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes