Trial Outcomes & Findings for Comparison Study of the ICON™ CPAP Series With and Without SensAwake™ (NCT NCT01831258)

Results Overview

Average used minutes (all days) taken from the CPAP device.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

70 participants

Primary outcome timeframe

2 weeks

Results posted on

2017-07-19

Participant Flow

Participant milestones

Participant milestones
Measure	SensAwake On, Then Followed by SensAwake Off The comfort feature 'SensAwake' will be turned on, followed by it off.	SensAwake Off, Then Followed by SensAwake On The comfort feature 'SensAwake' will be turned off, then followed by on.
Overall Study STARTED	35	35
Overall Study COMPLETED	30	32
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	SensAwake On, Then Followed by SensAwake Off The comfort feature 'SensAwake' will be turned on, followed by it off.	SensAwake Off, Then Followed by SensAwake On The comfort feature 'SensAwake' will be turned off, then followed by on.
Overall Study Withdrawal by Subject	2	1
Overall Study Lost to Follow-up	3	2

Baseline Characteristics

Only collected 65 participants data on age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=70 Participants Participants who were randomized to receive either SensAwake On or SensAwake Off
Age, Continuous	50.78 years STANDARD_DEVIATION 11.49 • n=65 Participants • Only collected 65 participants data on age
Sex: Female, Male Female	22 Participants n=68 Participants • Only collected n=68. Missing data for 2 participants.
Sex: Female, Male Male	46 Participants n=68 Participants • Only collected n=68. Missing data for 2 participants.

PRIMARY outcome

Timeframe: 2 weeks

Population: Adherence data could only be obtained for 61 participants

Average used minutes (all days) taken from the CPAP device.

Outcome measures

Outcome measures
Measure	SensAwake On n=61 Participants The comfort feature 'SensAwake' will be turned on	SensAwake Off n=61 Participants The comfort feature 'SensAwake' will be turned off
Adherence to CPAP Treatment	272.672 mins Standard Error 17.055	289.087 mins Standard Error 15.239

SECONDARY outcome

Timeframe: 4 weeks

Population: Data for 65 participant were available

Collected through the Epworth Sleepiness Scale (ESS) which is a subjective questionnaire and the participant answer 8 question with rating on the chance of dozing (from 0= no chance of dozing to 3 = high chance of dozing). The total is added with a range from 0-24. A total score of 0 means that the participant is not experiencing day time sleepiness, while total score of 24 means that the participant si extremely sleepy during the daytime.

Outcome measures

Outcome measures
Measure	SensAwake On n=65 Participants The comfort feature 'SensAwake' will be turned on	SensAwake Off n=65 Participants The comfort feature 'SensAwake' will be turned off
Daytime Sleepiness (Subjective Sleep Quality)	6.9 units on a scale Standard Error 0.6	6.4 units on a scale Standard Error 0.6

SECONDARY outcome

Timeframe: 4 weeks

Population: Data for 63 participant were available

Collected through the Insomnia Severity Index (ISI). There are seven question with each question having a scale of 0 (no issue) to 4 (very severe). The total score is added up. If the participant has a total score of 0-7 = no clinical significant insomnia, total score of 8-14 = sub threshold insomnia, total score of 15-21 = clinical insomnia (moderate), total score of 22-28 = clinical insomnia (severe).

Outcome measures

Outcome measures
Measure	SensAwake On n=63 Participants The comfort feature 'SensAwake' will be turned on	SensAwake Off n=63 Participants The comfort feature 'SensAwake' will be turned off
Insomnia Severity Index (Subjective Sleep Quality)	7.8 units on a scale Standard Error 0.8	7.3 units on a scale Standard Error 0.7

SECONDARY outcome

Timeframe: 4 weeks

Population: Data for 62 participant were available

Collected through the Short Functional Outcomes of Sleep Questionnaire (FOSQ-10). The questionnaire has 10 questions which ask how daytime sleepiness has impacted their quality of life. Each question has a scale of 1 = yes extreme to 4 = No. Lower total score (min 10) means that the disease is affecting your quality of life while a higher total score (maximum 40) means that the disease is not affecting your quality of life.

Outcome measures

Outcome measures
Measure	SensAwake On n=62 Participants The comfort feature 'SensAwake' will be turned on	SensAwake Off n=62 Participants The comfort feature 'SensAwake' will be turned off
OSA Impact of Daily Life	32.7 units on a scale Standard Error 1.0	34.6 units on a scale Standard Error 0.9

SECONDARY outcome

Timeframe: 4 weeks

Population: Data for 64 participant were available

Collected through the Fatigue Severity Scale (FSS). There are 9 question on fatigue with each question having a scale of 1 = strongly disagree and 7 = strongly agree. A lower total score (minimum of 9) = low severity with fatigue while a higher total score (maximum of 63) indicates a higher severity with fatigue.

Outcome measures

Outcome measures
Measure	SensAwake On n=64 Participants The comfort feature 'SensAwake' will be turned on	SensAwake Off n=64 Participants The comfort feature 'SensAwake' will be turned off
OSA Impact of Daily Life (Fatigue)	29.3 units on a scale Standard Error 1.6	28.2 units on a scale Standard Error 1.9

SECONDARY outcome

Timeframe: 4 weeks

Population: Data for 64 participant were available

Collected through the Patient Global Impression of Change (PGI).The questions ask "Since beginning CPAP therapy, how would you describe the chance (if any) in symptoms related to your OSA. The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference.

Outcome measures

Outcome measures
Measure	SensAwake On n=64 Participants The comfort feature 'SensAwake' will be turned on	SensAwake Off n=64 Participants The comfort feature 'SensAwake' will be turned off
Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Severity	4.3 units on a scale Standard Error 0.2	4.4 units on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: 4 weeks

Population: Data for 64 participant were available

Collected through the Patient Global Impression of Change (PGI).The questions ask "Since beginning CPAP therapy, how would you describe the change (if any) in overall quality of life related to your OSA?". The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference.

Outcome measures

Outcome measures
Measure	SensAwake On n=64 Participants The comfort feature 'SensAwake' will be turned on	SensAwake Off n=64 Participants The comfort feature 'SensAwake' will be turned off
Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Change	4.2 units on a scale Standard Error 0.2	4.3 units on a scale Standard Error 0.2

OTHER_PRE_SPECIFIED outcome

Timeframe: One night

Population: Obtained only 61 participant CPAP data.

The amount of Continuous Positive Airway Pressure (CPAP) leak was obtained through the device

Outcome measures

Outcome measures
Measure	SensAwake On n=61 Participants The comfort feature 'SensAwake' will be turned on	SensAwake Off n=61 Participants The comfort feature 'SensAwake' will be turned off
Leak	41.72 L/min Standard Error 2.52	48.91 L/min Standard Error 3.01

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks

Population: Only 61 participant data was available.

Collected through the device

Outcome measures

Outcome measures
Measure	SensAwake On n=61 Participants The comfort feature 'SensAwake' will be turned on	SensAwake Off n=61 Participants The comfort feature 'SensAwake' will be turned off
Apnea Hypopnea Index (AHI)	5.182 events/hour Standard Error 0.590	3.563 events/hour Standard Error 0.464

POST_HOC outcome

Timeframe: 4 weeks

Population: Only participant with moderate clinical insomnia (Insomnia Severity Index of 15 and over) were included in the post-hoc.

Adherence from the device (during their first treatment arm) in patients with moderate clinical insomnia (Insomnia Severity Index 15 or over)

Outcome measures

Outcome measures
Measure	SensAwake On n=18 Participants The comfort feature 'SensAwake' will be turned on	SensAwake Off n=12 Participants The comfort feature 'SensAwake' will be turned off
Adherence in Patients With Signs of Moderate Clinical Insomnia	322.89 minutes Standard Error 26.46	282.25 minutes Standard Error 30.58

POST_HOC outcome

Timeframe: 8 weeks

Population: Only participant with moderate clinical insomnia (Insomnia Severity Index of 15 and over) were included in the post-hoc.

Adherence from the device (during their entire study period) in patients with moderate clinical insomnia (Insomnia Severity Index 15 or over)

Outcome measures

Outcome measures
Measure	SensAwake On n=18 Participants The comfort feature 'SensAwake' will be turned on	SensAwake Off n=12 Participants The comfort feature 'SensAwake' will be turned off
Adherence in Patients With Signs of Moderate Clinical Insomnia	304.787 minutes Standard Error 28.75	238.42 minutes Standard Error 35.57

Adverse Events

SensAwake On

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

SensAwake Off

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SensAwake On n=70 participants at risk The comfort feature 'SensAwake' will be turned on	SensAwake Off n=70 participants at risk The comfort feature 'SensAwake' will be turned off
Blood and lymphatic system disorders High Blood Pressure	0.00% 0/70 • 1 year and 1 month	1.4% 1/70 • Number of events 1 • 1 year and 1 month

Other adverse events

Other adverse events
Measure	SensAwake On n=70 participants at risk The comfort feature 'SensAwake' will be turned on	SensAwake Off n=70 participants at risk The comfort feature 'SensAwake' will be turned off
Skin and subcutaneous tissue disorders Mask related issues	7.1% 5/70 • Number of events 5 • 1 year and 1 month	10.0% 7/70 • Number of events 7 • 1 year and 1 month
Respiratory, thoracic and mediastinal disorders Cold or Upper Respiratory Infections	4.3% 3/70 • Number of events 3 • 1 year and 1 month	7.1% 5/70 • Number of events 5 • 1 year and 1 month
Musculoskeletal and connective tissue disorders Broken Arm	0.00% 0/70 • 1 year and 1 month	1.4% 1/70 • Number of events 1 • 1 year and 1 month
Blood and lymphatic system disorders Dizziness upon Arousal	1.4% 1/70 • Number of events 1 • 1 year and 1 month	0.00% 0/70 • 1 year and 1 month
Respiratory, thoracic and mediastinal disorders Pressure related problems	2.9% 2/70 • Number of events 2 • 1 year and 1 month	2.9% 2/70 • Number of events 2 • 1 year and 1 month
Musculoskeletal and connective tissue disorders Scheduled Achilles Tendon Surgery	0.00% 0/70 • 1 year and 1 month	1.4% 1/70 • Number of events 1 • 1 year and 1 month

Additional Information

Dr Richard Bogan

SleepMed of South Carolina

Phone: 8777537633

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place