NCT00646477

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

March 28, 2008

Status Verified

March 1, 2008

Enrollment Period

7 months

First QC Date

March 25, 2008

Last Update Submit

March 25, 2008

Conditions

OSAS (Obstructive Sleep Apneas Syndrome)

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • To compare effective pressure Peff determined by the device and during manual titration

    May 2008

  • To compare the impact of the two-speed descent pressure algorithm

    May 2008

Study Arms (4)

A

EXPERIMENTAL

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

Device: titration night

B

EXPERIMENTAL

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

Device: titration night

C

EXPERIMENTAL

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

Device: titration night

D

EXPERIMENTAL

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

Device: titration night

Interventions

titration nightDEVICE

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.

ABCD

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Michalon, sleep disorders center

Grenoble, 38049, France

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Veronique Grillier-Lanoir

    Tyco Healthcare Group

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 25, 2008

First Posted

March 28, 2008

Study Start

October 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

March 28, 2008

Record last verified: 2008-03

Locations

FR(1)