ISIS 1 Therapeutic Effectiveness

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Tyco Healthcare Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tyco Healthcare Group
ClinicalTrials.gov Identifier:
NCT00646477
First received: March 25, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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

Condition Intervention Phase
OSAS (Obstructive Sleep Apneas Syndrome)
Device: titration night
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Therapeutic Efficacy Evaluation of the CPAP/autoCPAP Sandman in the Treatment of New Patients With Obstructive Sleep Apnoea Syndrome

Resource links provided by NLM:


Further study details as provided by Tyco Healthcare Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare effective pressure Peff determined by the device and during manual titration [ Time Frame: May 2008 ] [ Designated as safety issue: No ]
  • To compare the impact of the two-speed descent pressure algorithm [ Time Frame: May 2008 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: October 2007
Estimated Study Completion Date: May 2008
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646477

Locations
France
Hospital Michalon, sleep disorders center Recruiting
Grenoble, France, 38049
Contact: Jean-Louis PEPIN, Pr    +33 4 76 76 55 16    JLPepin@chu-grenoble.fr   
Principal Investigator: Patrick Levy, Pr         
Sub-Investigator: Jean-Louis Pepin, Pr         
Sub-Investigator: Renaud Tamisier, Dr         
Sponsors and Collaborators
Tyco Healthcare Group
Investigators
Study Chair: Veronique Grillier-Lanoir Tyco Healthcare Group
  More Information

No publications provided

Responsible Party: EMEA Clinical Affairs - Respiratory & Monitoring Solutions, Tyco Healthcare Group
ClinicalTrials.gov Identifier: NCT00646477     History of Changes
Other Study ID Numbers: ISIS 1
Study First Received: March 25, 2008
Last Updated: March 25, 2008
Health Authority: France: French Data Protection Authority

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 22, 2014