Overview Of Clinical Studies And Publications

Question 1

Answer 1

Question 2

Answer 2

Question 3

Answer 3

Question 4

Answer 4

Question 5

What type of study was the dream study?

Answer 5

Multi center, prospective, open label, interventional

Question 6

How many patients were enrolled in the dream study and how long was it?

Answer 6

115, 12 months

Question 7

What two factors did the dream study look at and what do they stand for?

Answer 7

AHI (apnea hypoxia index) and ODI (oxygen desaturation index)

Question 8

What was the AHI responder rate of the dream study?

Answer 8

63.5%

Question 9

What was the ODI responder rate of the dream study?

Answer 9

71.3%

Question 10

What was the median reduction of AHI at the 13 month PSG in the dream study?

Answer 10

70.8%

Question 11

What was the median reduction of AHI at the 13 month PSG in the dream study?

Answer 11

70.8%

Question 12

In the dream study, what was the overall SAE (serious adverse events) percentage and what percentage was device related?

Answer 12

8.7%, 2.6%

Question 13

In the dream study, what was the mean baseline AHI and ODI

Answer 13

AHI: 28
ODI: 27

Question 14

What was the mean baseline BMI for patients in the dream study?

Answer 14

28.5

Question 15

True or false, in the dream study, patients had similar ahi reductions in supine and non supine positioning

Answer 15

True

Question 16

What type of study was the BLAST study?

Answer 16

Single arm, non randomized, prospective

Question 17

What were the primary endpoints of the BLAST study?

Answer 17

1) SAE at 6 months
2) AHI change from baseline at 6 months

Question 18

What were the primary outcomes of the BLAST study

Answer 18

1) no serious adverse events at 6 months
2) AHI reduction of events per hour by 47.3%
2) ODI reduction of events per hour by 43.3%

Question 19

What are 3 take aways of the BLAST study

Answer 19

1) study reached all safety and efficacy end points
2) statistically significant reduction in AHI and ODI
3) AHI SHER responder rate: 50%, ODI responder rate: 77.3%

Question 20

What were the 3 takeaways of the Better Sleep Study?

Answer 20

1) better sleep study reached all efficacy endpoints
2) statistically significant AHI and ODI reduction in full cohort, CCC cohort, non CCC cohort
3) similar improvements in AHI and ODI for both CCC and non CCC participants

Question 21

What type of study was the BETTER SLEEP study

Answer 21

Multi center, prospective, open label, two group

Question 22

What study included CCC (complete centric collapse) patients

Answer 22

BETTER SLEEP