ISIS 1 Therapeutic Effectiveness

Tyco Healthcare Group

Status and phase: Unknown; Phase 3

Conditions: OSAS (Obstructive Sleep Apneas Syndrome)

Treatments: Device: titration night

Study type: Interventional

Funder types: Industry

Identifiers

NCT00646477

ISIS 1

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

A

Experimental group

Description:

Phase 1 : manual Phase 2 : automatic Descent rate pressure : slow

Treatment:

Device: titration night

B

Experimental group

Description:

Phase 1 : manual Phase 2 : automatic Descent Rate Pressure : fast

Treatment:

Device: titration night

C

Experimental group

Description:

Phase 1 : automatic Phase 2 : manual Descent rate pressure : slow

Treatment:

Device: titration night

D

Experimental group

Description:

Phase 1 : automatic Phase 2 : manual Descent Rate Pressure : fast

Treatment:

Device: titration night