Trial Outcomes & Findings for Real-time Attended Home-polysomnography Through Telematic Data Transmission (NCT NCT01471626)

NCT ID: NCT01471626

Last Updated: 2012-10-05

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: 1 week
• Results posted on: 2012-10-05

Participant Flow

Recruitment took place in the Sleep Lab of a tertiary hospital. Patients were recruted for ploysomnography if they were clinically suspicted of OSA.

Participant milestones

Measure	Telematic Attended Polysomnography All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype. The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors.
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Real-time Attended Home-polysomnography Through Telematic Data Transmission

Baseline characteristics by cohort

Measure	Telematic Attended Polysomnography n=21 Participants All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype. The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age Continuous	50 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment Belgium	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

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.

Outcome measures

Measure

Telematic Attended Polysomnography n=21 Participants All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype. The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors.

Quality of Polysomnographic Recordings

10 percentage of recording failure

Adverse Events

Telematic Attended Polysomnography

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Marie Bruyneel

CHU St Pierre

Phone: 003225354219

Email: marie_bruyneel@tpierre-bru.be

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place