Trial Outcomes & Findings for Evaluation of ApneaLink Plus Scoring Capabilities (NCT NCT00823134)

NCT ID: NCT00823134

Last Updated: 2020-05-12

Results Overview

Apnoea is defined as a decrease in flow of ≥90% from baseline for at least 10 seconds; hypopnea is a decrease in flow ≥30% from baseline for at least 10 seconds and an oxygen desaturation of ≥4%; obstructive: breathing efforts are ongoing; central: no breathing efforts

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 23 participants
• Primary outcome timeframe: one night
• Results posted on: 2020-05-12

Participant Flow

Participant milestones

Measure	PSG/ApneaLink Sleep Evaluation under Polysomnography and with ApneaLink
Overall Study STARTED	23
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	PSG/ApneaLink Sleep Evaluation under Polysomnography and with ApneaLink
Overall Study Invalid measurement	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	PSG/ApneaLink n=22 Participants Sleep Evaluation under Polysomnography and with ApneaLink
Age, Continuous	53.73 years STANDARD_DEVIATION 16.26 • n=22 Participants
Sex: Female, Male Female	3 Participants n=22 Participants
Sex: Female, Male Male	19 Participants n=22 Participants
Region of Enrollment Germany	22 participants n=22 Participants
Body Mass Index	29.77 kg/m2 STANDARD_DEVIATION 4.23 • n=22 Participants

PRIMARY outcome

Timeframe: one night

Apnoea is defined as a decrease in flow of ≥90% from baseline for at least 10 seconds; hypopnea is a decrease in flow ≥30% from baseline for at least 10 seconds and an oxygen desaturation of ≥4%; obstructive: breathing efforts are ongoing; central: no breathing efforts

Outcome measures

Measure	PSG/ApneaLink n=22 Participants Sleep Evaluation under Polysomnography and with ApneaLink
Assessment of the Apnoea-Hypopnea-Index (Number of Apneas (All Apneas, Obstructive, Mixed, Central) and Number of Hypopneas) Between ApneaLink Plus and a PSG System Within the Same Evaluation Period AHI_psg	14.77 events/hour Standard Deviation 14.97
Assessment of the Apnoea-Hypopnea-Index (Number of Apneas (All Apneas, Obstructive, Mixed, Central) and Number of Hypopneas) Between ApneaLink Plus and a PSG System Within the Same Evaluation Period AHI_al	12.14 events/hour Standard Deviation 12.04

PRIMARY outcome

Timeframe: 1 night

Population: Participant undergoes one night of sleep while wearing an Apnea Link device and polysomnography is being recorded.

The AHI (PSG) values and AHI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of >75% will be seen as threshold for validity.

Outcome measures

Measure	PSG/ApneaLink n=22 Participants Sleep Evaluation under Polysomnography and with ApneaLink
Correlation Coefficient of Apnoea-Hypopnea-Index (AHI) (PSG) - AHI (AL)	0.968 correlation

PRIMARY outcome

Timeframe: 1 night

Population: Participant undergoes one night of sleep while wearing an Apnea Link device and polysomnography is being recorded.

The AI (PSG) values and AI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of >75% will be seen as threshold for validity.

Outcome measures

Measure	PSG/ApneaLink n=22 Participants Sleep Evaluation under Polysomnography and with ApneaLink
Correlation Coefficient of Apnoea-Index (AI) (PSG) - AI (AL)	0.935 Correlation

PRIMARY outcome

Timeframe: 1 night

Population: Participant undergoes one night of sleep while wearing an Apnea Link device and polysomnography is being recorded.

The OAI (PSG) values and OAI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of >75% will be seen as threshold for validity.

Outcome measures

Measure	PSG/ApneaLink n=22 Participants Sleep Evaluation under Polysomnography and with ApneaLink
Correlation Coefficient of Obstructive-Apnoea-Index (OAI) (PSG) - OAI (AL)	0.852 Correlation

PRIMARY outcome

Timeframe: 1 night

Population: Participant undergoes one night of sleep while wearing an Apnea Link device and polysomnography is being recorded.

The CAI (PSG) values and CAI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of >75% will be seen as threshold for validity.

Outcome measures

Measure	PSG/ApneaLink n=22 Participants Sleep Evaluation under Polysomnography and with ApneaLink
Correlation Coefficient of Central-Apnoea-Index (CAI) (PSG) - CAI (AL)	0.939 Correlation

PRIMARY outcome

Timeframe: 1 night

Population: Participant undergoes one night of sleep while wearing an Apnea Link device and polysomnography is being recorded.

The HI (PSG) values and HI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of >75% will be seen as threshold for validity.

Outcome measures

Measure	PSG/ApneaLink n=22 Participants Sleep Evaluation under Polysomnography and with ApneaLink
Correlation Coefficient of Apnoea-Index (HI) (PSG) - HI (AL)	0.754 Correlation

PRIMARY outcome

Timeframe: 1 night

Population: Participant undergoes one night of sleep while wearing an Apnea Link device and polysomnography is being recorded.

The ODI (PSG) values and ODI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of >75% will be seen as threshold for validity.

Outcome measures

Measure	PSG/ApneaLink n=22 Participants Sleep Evaluation under Polysomnography and with ApneaLink
Correlation Coefficient of Obstructive-Apnoea-Index (ODI) (PSG) - ODI (AL)	0.905 Correlation

Adverse Events

PSG/ApneaLink

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

Oliver Munt

ResMed Germany Inc

Phone: 0899901

Email: oliver.munt@resmed.de

Results disclosure agreements

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