Trial Outcomes & Findings for Complex Sleep Apnea Syndrome (CompSAS) Resolution Study (NCT NCT00915499)

NCT ID: NCT00915499

Last Updated: 2013-02-28

Results Overview

AHI refers to the number of apneas and hypopneas that occurred per hour of sleep

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 66 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2013-02-28

Participant Flow

Participant milestones

Measure	ASV Mode VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea	CPAP Mode VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
Overall Study STARTED	33	33
Overall Study COMPLETED	29	31
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Complex Sleep Apnea Syndrome (CompSAS) Resolution Study

Baseline characteristics by cohort

Measure	ASV Mode n=33 Participants VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea	CPAP Mode n=33 Participants VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea	Total n=66 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Age Continuous	59.1 years STANDARD_DEVIATION 14.2 • n=5 Participants	59.4 years STANDARD_DEVIATION 11.7 • n=7 Participants	59.2 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	30 Participants n=7 Participants	56 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	33 participants n=7 Participants	66 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

AHI refers to the number of apneas and hypopneas that occurred per hour of sleep

Outcome measures

Measure	ASV Mode n=29 Participants Positive airway pressure in the adaptive servo-ventilation (ASV) mode	CPAP Mode n=31 Participants Positive airway pressure in the continuous positive airway pressure (CPAP) mode
Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period	4.4 AHI (events/hour) Standard Deviation 9.6	9.9 AHI (events/hour) Standard Deviation 11.1

SECONDARY outcome

Timeframe: 3 months

Likert scale measured from 0-7. The minimum important difference a change of 0.5 when a 7-item Likert scale is used. 0 represents the most negative response, 7 represents the most positive response.

Outcome measures

Measure	ASV Mode n=30 Participants Positive airway pressure in the adaptive servo-ventilation (ASV) mode	CPAP Mode n=31 Participants Positive airway pressure in the continuous positive airway pressure (CPAP) mode
Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI) Baseline SAQLI score	4.6 units on a scale Standard Deviation 1.2	4.5 units on a scale Standard Deviation 0.9
Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI) End of study SAQLI score	4.7 units on a scale Standard Deviation 0.9	4.6 units on a scale Standard Deviation 1.1

Adverse Events

ASV Mode

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

CPAP Mode

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	ASV Mode n=33 participants at risk VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea	CPAP Mode n=33 participants at risk VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/33	3.0% 1/33 • Number of events 1
Cardiac disorders Heart attack	0.00% 0/33	3.0% 1/33 • Number of events 1
Cardiac disorders Rebound hypertension	0.00% 0/33	3.0% 1/33 • Number of events 1

Other adverse events

Measure	ASV Mode n=33 participants at risk VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea	CPAP Mode n=33 participants at risk VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
Skin and subcutaneous tissue disorders Facial irritation/rash	9.1% 3/33 • Number of events 3	9.1% 3/33 • Number of events 3
Skin and subcutaneous tissue disorders Skin breakdown (from mask)	9.1% 3/33 • Number of events 3	12.1% 4/33 • Number of events 4
Respiratory, thoracic and mediastinal disorders Respiratory tract infection	3.0% 1/33 • Number of events 1	6.1% 2/33 • Number of events 2
Respiratory, thoracic and mediastinal disorders Other sinus issues	6.1% 2/33 • Number of events 2	6.1% 2/33 • Number of events 2

Additional Information

June Mendoza

ResMed

Phone: 1-800-424-0737

Email: june.mendoza@resmed.com

Results disclosure agreements

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

Restriction type: LTE60