ISIS 1 Therapeutic Effectiveness

March 25, 2008 updated by: Tyco Healthcare Group

Therapeutic Efficacy Evaluation of the CPAP/autoCPAP Sandman in the Treatment of New Patients With Obstructive Sleep Apnoea Syndrome

The study is a prospective field evaluation to assess the therapeutic value of the CPAP/autoCPAP Sandman in 24 new diagnosed Obstructive Sleep Apneic patients.

Precisely, the study was designed to :

  • evaluate the therapeutic efficacy of the CPAP/autoCPAP Sandman device in improving sleep quality and normalozing respiratory events
  • determine the sensitivity and specificity of the device in adequately detecting respiratroy events
  • compare effective pressure Peff determined by the device and during manual titration
  • compare the impact of the two-speed descent pressure algorithm

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

During the study, each patient underwent one night of full polysomnography with two consecutives therapeutic sequences during the same night, after randomization of the passage order:

  • autotitrating pressure phase: sleep parameters and respiratory events vs results of the polysomnographic registration,
  • manual titration phase: concordance between events respiratory analyzed on the polysomnographic recordings and the events detected by the CPAP / auto-CPAP.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38049
        • Recruiting
        • Hospital Michalon, sleep disorders center
        • Contact:
        • Principal Investigator:
          • Patrick Levy, Pr
        • Sub-Investigator:
          • Renaud Tamisier, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patient male or female, aged 18 to 75 years
  • weight > 30kg
  • patient with a newly diagnosed OSAS, under treatment with CPAP
  • patient in stable condition
  • patient affiliated to a social security insurance
  • having given its written informed consent to participate to the study

Exclusion Criteria:

  • pneumothorax or pneumomediastin history
  • massive epistaxis (current or previous)
  • decompensated heart failure or hypotension
  • pneumoencephal history, recent trauma or surgery sequel with cranio-nasopharyngeal fistula
  • acute sinusitis history, middle ear infection or perforation of the tympanic membrane
  • respiratory insufficiency or severe respiratory illness with the possibility of residual hypoxemia
  • severe bullous emphysema or previously complicated pneumothorax
  • severe claustrophobia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
Phase 1 : manual Phase 2 : automatic Descent rate pressure : slow
Device: titration night

Each subject undergo 1 night of full polysomnography split into 2 consecutives and randomized sequences, using the Sandman device into two different modes:

in APAP mode - Data analysis of this sequence will be used to evaluate the therapeutic effectiveness of the CPAP/autoCPAP Sandman in APAP mode compared both to the polysomnography registration and the diagnosis night for each enrolled patient. The type of respiratory events and their index/hour of sleep and the total arousal index will be appraised as markers of the efficacy of OSAS treatment, constituting the primary outcomes.

in CPAP mode for manual titration sequence.During the manual titration, 5 constant pressure levels settings were studied for equal periods of 30 minutes gradually increasing the pressure. The aim of this sequence is to determine the sensitivity and the specificity of the CPAP/autoCPAP Sandman in detecting respiratory events.
EXPERIMENTAL: B
Phase 1 : manual Phase 2 : automatic Descent Rate Pressure : fast
Device: titration night

Each subject undergo 1 night of full polysomnography split into 2 consecutives and randomized sequences, using the Sandman device into two different modes:

in APAP mode - Data analysis of this sequence will be used to evaluate the therapeutic effectiveness of the CPAP/autoCPAP Sandman in APAP mode compared both to the polysomnography registration and the diagnosis night for each enrolled patient. The type of respiratory events and their index/hour of sleep and the total arousal index will be appraised as markers of the efficacy of OSAS treatment, constituting the primary outcomes.

in CPAP mode for manual titration sequence.During the manual titration, 5 constant pressure levels settings were studied for equal periods of 30 minutes gradually increasing the pressure. The aim of this sequence is to determine the sensitivity and the specificity of the CPAP/autoCPAP Sandman in detecting respiratory events.
EXPERIMENTAL: C
Phase 1 : automatic Phase 2 : manual Descent rate pressure : slow
Device: titration night

Each subject undergo 1 night of full polysomnography split into 2 consecutives and randomized sequences, using the Sandman device into two different modes:

in APAP mode - Data analysis of this sequence will be used to evaluate the therapeutic effectiveness of the CPAP/autoCPAP Sandman in APAP mode compared both to the polysomnography registration and the diagnosis night for each enrolled patient. The type of respiratory events and their index/hour of sleep and the total arousal index will be appraised as markers of the efficacy of OSAS treatment, constituting the primary outcomes.

in CPAP mode for manual titration sequence.During the manual titration, 5 constant pressure levels settings were studied for equal periods of 30 minutes gradually increasing the pressure. The aim of this sequence is to determine the sensitivity and the specificity of the CPAP/autoCPAP Sandman in detecting respiratory events.
EXPERIMENTAL: D
Phase 1 : automatic Phase 2 : manual Descent Rate Pressure : fast
Device: titration night

Each subject undergo 1 night of full polysomnography split into 2 consecutives and randomized sequences, using the Sandman device into two different modes:

in APAP mode - Data analysis of this sequence will be used to evaluate the therapeutic effectiveness of the CPAP/autoCPAP Sandman in APAP mode compared both to the polysomnography registration and the diagnosis night for each enrolled patient. The type of respiratory events and their index/hour of sleep and the total arousal index will be appraised as markers of the efficacy of OSAS treatment, constituting the primary outcomes.

in CPAP mode for manual titration sequence.During the manual titration, 5 constant pressure levels settings were studied for equal periods of 30 minutes gradually increasing the pressure. The aim of this sequence is to determine the sensitivity and the specificity of the CPAP/autoCPAP Sandman in detecting respiratory events.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the sensitivity and specificity of the CPAP/autoCPAP Sandman in adequately detecting respiratory events and to evaluate the therapeutic effectiveness of the device in improving sleep quality and normalizing respiratory events
Time Frame: May 2008
May 2008

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare effective pressure Peff determined by the device and during manual titration
Time Frame: May 2008
May 2008
To compare the impact of the two-speed descent pressure algorithm
Time Frame: May 2008
May 2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tyco Healthcare Group

Investigators

  • Study Chair: Veronique Grillier-Lanoir, Tyco Healthcare Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (ANTICIPATED)

May 1, 2008

Study Completion (ANTICIPATED)

May 1, 2008

Study Registration Dates

First Submitted

March 25, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (ESTIMATE)

March 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 28, 2008

Last Update Submitted That Met QC Criteria

March 25, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISIS 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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