NCT01471626

Brief Summary

The purpose of this study is to develop an efficient home-based polysomnography device, which allows, through GPRS,continuous real-time monitoring from the sleep lab based in the hospital, in order to decrease the failure rate of home-based recordings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 10, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 15, 2011

Completed
16 days until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
7 months until next milestone

Results Posted

Study results publicly available

October 5, 2012

Completed
Last Updated

October 5, 2012

Status Verified

September 1, 2012

Enrollment Period

2 months

First QC Date

October 10, 2011

Results QC Date

May 29, 2012

Last Update Submit

September 6, 2012

Conditions

Obstructive Sleep Apnea

Keywords

sleep apneapolysomnographytelemedicine

Outcome Measures

Primary Outcomes (1)

  • Quality of Polysomnographic Recordings

    Quality of recordings will be graded according to Redline S et al (SLEEP 1998): Unsatisfactory, poor, fair, good, very good,excellent. Unsatisfactory and poor recordings are considered as failures.

    1 week

Study Arms (1)

telematic attended polysomnography

EXPERIMENTAL
Device: polysomnograph Dream and Sleep Box

Interventions

polysomnograph Dream and Sleep BoxDEVICE

Portable polysomnograph will be placed at home around 7:00PM. The Sleep Box (wireless monitoring device) will be left near the patient, to allow real-time GPRS transmission of recorded sleep parameters to the sleep lab.

telematic attended polysomnography

Eligibility Criteria

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

You may qualify if:

  • clinical suspicion of OSA
  • y old

You may not qualify if:

  • restrictive respiratory disorders
  • distance home-hospital exceeding 30 Km.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU St Pierre

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Limitations and Caveats

-technical problems with the Skype® connection

Results Point of Contact

Title
Dr Marie Bruyneel
Organization
CHU St Pierre
marie_bruyneel@tpierre-bru.be
003225354219

Study Officials

  • Marie Bruyneel, MD

    CHU St Pierre

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
pneumologist, chef de clinique adjoint

Study Record Dates

First Submitted

October 10, 2011

First Posted

November 15, 2011

Study Start

December 1, 2011

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

October 5, 2012

Results First Posted

October 5, 2012

Record last verified: 2012-09

Locations

BE(1)