ISIS 1 Therapeutic Effectiveness

OSAS (Obstructive Sleep Apneas Syndrome) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00646477
• Other study ID #: ISIS 1
• Status: Recruiting
• Phase: Phase 3
• First received: March 25, 2008
• Last updated: March 25, 2008
• Start date: October 2007
• Est. completion date: May 2008

Study information

• Verified date: March 2008
• Source: Tyco Healthcare Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• OSAS (Obstructive Sleep Apneas Syndrome)
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
France	Hospital Michalon, sleep disorders center	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
Tyco Healthcare Group

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		May 2008	No
Secondary	To compare effective pressure Peff determined by the device and during manual titration		May 2008	No
Secondary	To compare the impact of the two-speed descent pressure algorithm		May 2008	No