Trial Outcomes & Findings for Trial of Effects of Oral Xyrem and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients (NCT NCT00086281)
NCT ID: NCT00086281
Last Updated: 2012-02-24
Results Overview
The AHI was defined as the incidence(events per hour) of apnea and hypopnea events associated with sleep, determined from the overnight polysomnogram (PSG). An apnea event is characterized by a cessation in airflow lasting \>= 10 seconds, accompanied by oxygen desaturation of \>3% or arousal. An Hyponea event is characterized by a transient reduction in breathing lasting \>= 10 seconds, with clear decrease (\>50%) from baseline in the amplitude of breathing or a decrease \<50% in the amplitude of breathing accompanied by oxygen desaturation of \>3% or arousal.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
One night of PSG during one night of treatment each per arm.
Results posted on
2012-02-24
Participant Flow
Participant milestones
| Measure |
P Then X Then Z With P Then X With M
Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
|
X Then X With M Then P Then Z With P
Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
|
X With M Then Z With P Then X Then P
Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later.
|
Z With P Then P Then X With M Then X
Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
|
P Then X Then P Then X With M Then Z With P
Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
|
X Then Z With P Then X With M Then P
Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later.
|
X Then Z With P Then P Then X With M
Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
|
X Then X Then P Then Z With P
Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
|
X With M Then X Then P Then Z With P
Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
|
P Then X Then Z With P
Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
|
Z With P Then P Then X With M
Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
|
P Then X
Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
|
Placebo
Placebo was given at bedtime and again 2.5 to 4 hours later
|
Xyrem
Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
|
X With M
Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1
STARTED
|
11
|
12
|
8
|
11
|
1
|
3
|
1
|
1
|
2
|
1
|
3
|
1
|
1
|
1
|
3
|
|
Phase 1
COMPLETED
|
11
|
12
|
8
|
11
|
1
|
3
|
1
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
1
|
1
|
1
|
3
|
|
Phase 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
23
|
27
|
0
|
|
Phase 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
22
|
26
|
0
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
P Then X Then Z With P Then X With M
Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
|
X Then X With M Then P Then Z With P
Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
|
X With M Then Z With P Then X Then P
Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later.
|
Z With P Then P Then X With M Then X
Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
|
P Then X Then P Then X With M Then Z With P
Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
|
X Then Z With P Then X With M Then P
Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later.
|
X Then Z With P Then P Then X With M
Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
|
X Then X Then P Then Z With P
Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
|
X With M Then X Then P Then Z With P
Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
|
P Then X Then Z With P
Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
|
Z With P Then P Then X With M
Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
|
P Then X
Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
|
Placebo
Placebo was given at bedtime and again 2.5 to 4 hours later
|
Xyrem
Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
|
X With M
Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
1
|
1
|
1
|
2
|
|
Phase 1
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Phase 1
Serious Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Phase 2
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Trial of Effects of Oral Xyrem and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients
Baseline characteristics by cohort
| Measure |
P Then X Then Z With P Then X With M
n=11 Participants
Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
|
X Then X With M Then P Then Z With P
n=12 Participants
Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
|
X With M Then Z With P Then X Then P
n=8 Participants
Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later.
|
Z With P Then P Then X With M Then X
n=11 Participants
Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
|
P Then X Then P Then X With M Then Z With P
n=1 Participants
Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
|
X Then Z With P Then X With M Then P
n=3 Participants
Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later.
|
X Then Z With P Then P Then X With M
n=1 Participants
Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
|
X Then X Then P Then Z With P
n=1 Participants
Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
|
X With M Then X Then P Then Z With P
n=2 Participants
Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
|
P Then X Then Z With P
n=1 Participants
Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
|
Z With P Then P Then X With M
n=3 Participants
Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
|
P Then X
n=1 Participants
Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
|
Placebo
n=1 Participants
Placebo was given at bedtime and again 2.5 to 4 hours later
|
Xyrem
n=1 Participants
Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
|
X With M
n=3 Participants
Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age Continuous
|
50.9 years
STANDARD_DEVIATION 9.63 • n=5 Participants
|
46.3 years
STANDARD_DEVIATION 11.39 • n=7 Participants
|
49.4 years
STANDARD_DEVIATION 4.44 • n=5 Participants
|
50.5 years
STANDARD_DEVIATION 8.45 • n=4 Participants
|
49.0 years
STANDARD_DEVIATION 0 • n=21 Participants
|
47.3 years
STANDARD_DEVIATION 6.11 • n=10 Participants
|
61.0 years
STANDARD_DEVIATION 0 • n=115 Participants
|
42.0 years
STANDARD_DEVIATION 0 • n=24 Participants
|
64.0 years
STANDARD_DEVIATION 18.38 • n=42 Participants
|
43.0 years
STANDARD_DEVIATION 0 • n=42 Participants
|
59.3 years
STANDARD_DEVIATION 7.77 • n=42 Participants
|
63.0 years
STANDARD_DEVIATION 0 • n=42 Participants
|
61.0 years
STANDARD_DEVIATION 0 • n=36 Participants
|
36.0 years
STANDARD_DEVIATION 0 • n=36 Participants
|
48.0 years
STANDARD_DEVIATION 7.00 • n=24 Participants
|
50.2 years
STANDARD_DEVIATION 9.59 • n=135 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
14 Participants
n=135 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
46 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
54 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
PRIMARY outcome
Timeframe: One night of PSG during one night of treatment each per arm.The AHI was defined as the incidence(events per hour) of apnea and hypopnea events associated with sleep, determined from the overnight polysomnogram (PSG). An apnea event is characterized by a cessation in airflow lasting \>= 10 seconds, accompanied by oxygen desaturation of \>3% or arousal. An Hyponea event is characterized by a transient reduction in breathing lasting \>= 10 seconds, with clear decrease (\>50%) from baseline in the amplitude of breathing or a decrease \<50% in the amplitude of breathing accompanied by oxygen desaturation of \>3% or arousal.
Outcome measures
| Measure |
Placebo
n=50 Participants
Placebo
|
Xyrem
n=50 Participants
Xyrem
|
Xyrem + Modafinil
n=49 Participants
Xyrem + Modafinil
|
Zolpidem + Placebo
n=50 Participants
Zolpidem + Placebo
|
|---|---|---|---|---|
|
The Primary Efficacy Variable Was the Mean Apnea-Hypopnea Index (AHI).
|
22.33 Apnea + Hypopnea episodes per hour
Standard Deviation 10.836
|
18.18 Apnea + Hypopnea episodes per hour
Standard Deviation 11.280
|
21.10 Apnea + Hypopnea episodes per hour
Standard Deviation 13.463
|
22.71 Apnea + Hypopnea episodes per hour
Standard Deviation 10.618
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Xyrem
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
X + M
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Z + P
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=56 participants at risk
Placebo
|
Xyrem
n=53 participants at risk
Xyrem
|
X + M
n=55 participants at risk
Xyrem + Modafinil
|
Z + P
n=54 participants at risk
Zolpidem + Placebo
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/56
|
0.00%
0/53
|
1.8%
1/55
|
0.00%
0/54
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/56
|
0.00%
0/53
|
1.8%
1/55
|
0.00%
0/54
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/56
|
0.00%
0/53
|
1.8%
1/55
|
0.00%
0/54
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/56
|
0.00%
0/53
|
1.8%
1/55
|
0.00%
0/54
|
Other adverse events
| Measure |
Placebo
n=56 participants at risk
Placebo
|
Xyrem
n=53 participants at risk
Xyrem
|
X + M
n=55 participants at risk
Xyrem + Modafinil
|
Z + P
n=54 participants at risk
Zolpidem + Placebo
|
|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/56
|
0.00%
0/53
|
0.00%
0/55
|
1.9%
1/54
|
|
Cardiac disorders
Ventricular Extrasystoles
|
1.8%
1/56
|
0.00%
0/53
|
0.00%
0/55
|
0.00%
0/54
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/56
|
1.9%
1/53
|
0.00%
0/55
|
0.00%
0/54
|
|
Eye disorders
Asthenopia
|
1.8%
1/56
|
0.00%
0/53
|
0.00%
0/55
|
0.00%
0/54
|
|
Eye disorders
Eye Pain
|
1.8%
1/56
|
0.00%
0/53
|
0.00%
0/55
|
0.00%
0/54
|
|
Eye disorders
Vision Blurred
|
0.00%
0/56
|
1.9%
1/53
|
0.00%
0/55
|
0.00%
0/54
|
|
Gastrointestinal disorders
Abdominal Distension
|
1.8%
1/56
|
0.00%
0/53
|
0.00%
0/55
|
0.00%
0/54
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.8%
1/56
|
0.00%
0/53
|
0.00%
0/55
|
0.00%
0/54
|
|
Gastrointestinal disorders
Constipation
|
1.8%
1/56
|
0.00%
0/53
|
0.00%
0/55
|
0.00%
0/54
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/56
|
3.8%
2/53
|
0.00%
0/55
|
1.9%
1/54
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/56
|
0.00%
0/53
|
1.8%
1/55
|
0.00%
0/54
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/56
|
1.9%
1/53
|
0.00%
0/55
|
0.00%
0/54
|
|
Gastrointestinal disorders
Nausea
|
5.4%
3/56
|
1.9%
1/53
|
12.7%
7/55
|
5.6%
3/54
|
|
Gastrointestinal disorders
Stomach Discomfort
|
0.00%
0/56
|
0.00%
0/53
|
1.8%
1/55
|
0.00%
0/54
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/56
|
0.00%
0/53
|
5.5%
3/55
|
0.00%
0/54
|
|
General disorders
Fatigue
|
3.6%
2/56
|
0.00%
0/53
|
3.6%
2/55
|
0.00%
0/54
|
|
General disorders
Feeling Abnormal
|
0.00%
0/56
|
0.00%
0/53
|
1.8%
1/55
|
1.9%
1/54
|
|
Infections and infestations
Bronchitis
|
1.8%
1/56
|
0.00%
0/53
|
0.00%
0/55
|
0.00%
0/54
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/56
|
0.00%
0/53
|
1.8%
1/55
|
0.00%
0/54
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/56
|
0.00%
0/53
|
1.8%
1/55
|
0.00%
0/54
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/56
|
0.00%
0/53
|
0.00%
0/55
|
1.9%
1/54
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/56
|
1.9%
1/53
|
0.00%
0/55
|
0.00%
0/54
|
|
Injury, poisoning and procedural complications
Tooth Injury
|
1.8%
1/56
|
0.00%
0/53
|
0.00%
0/55
|
0.00%
0/54
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/56
|
0.00%
0/53
|
1.8%
1/55
|
0.00%
0/54
|
|
Investigations
Oxygen Saturation Decreased
|
0.00%
0/56
|
1.9%
1/53
|
0.00%
0/55
|
0.00%
0/54
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/56
|
1.9%
1/53
|
0.00%
0/55
|
0.00%
0/54
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/56
|
0.00%
0/53
|
1.8%
1/55
|
0.00%
0/54
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.8%
1/56
|
0.00%
0/53
|
0.00%
0/55
|
0.00%
0/54
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/56
|
0.00%
0/53
|
0.00%
0/55
|
1.9%
1/54
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
1.8%
1/56
|
0.00%
0/53
|
0.00%
0/55
|
0.00%
0/54
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/56
|
0.00%
0/53
|
1.8%
1/55
|
1.9%
1/54
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.00%
0/56
|
1.9%
1/53
|
0.00%
0/55
|
0.00%
0/54
|
|
Nervous system disorders
Disturbance in Attention
|
0.00%
0/56
|
1.9%
1/53
|
1.8%
1/55
|
0.00%
0/54
|
|
Nervous system disorders
Dizziness
|
0.00%
0/56
|
7.5%
4/53
|
5.5%
3/55
|
0.00%
0/54
|
|
Nervous system disorders
Headache
|
10.7%
6/56
|
9.4%
5/53
|
16.4%
9/55
|
5.6%
3/54
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/56
|
0.00%
0/53
|
3.6%
2/55
|
0.00%
0/54
|
|
Nervous system disorders
Mental Impairment
|
0.00%
0/56
|
0.00%
0/53
|
1.8%
1/55
|
0.00%
0/54
|
|
Nervous system disorders
Somnolence
|
1.8%
1/56
|
1.9%
1/53
|
0.00%
0/55
|
1.9%
1/54
|
|
Nervous system disorders
Syncope Vasovagal
|
1.8%
1/56
|
0.00%
0/53
|
0.00%
0/55
|
0.00%
0/54
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/56
|
0.00%
0/53
|
3.6%
2/55
|
0.00%
0/54
|
|
Psychiatric disorders
Disorientation
|
1.8%
1/56
|
0.00%
0/53
|
0.00%
0/55
|
0.00%
0/54
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/56
|
1.9%
1/53
|
0.00%
0/55
|
3.7%
2/54
|
|
Psychiatric disorders
Panic Attack
|
0.00%
0/56
|
0.00%
0/53
|
1.8%
1/55
|
0.00%
0/54
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.8%
1/56
|
0.00%
0/53
|
0.00%
0/55
|
0.00%
0/54
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/56
|
3.8%
2/53
|
1.8%
1/55
|
0.00%
0/54
|
|
Renal and urinary disorders
Urine Abnormality
|
1.8%
1/56
|
0.00%
0/53
|
0.00%
0/55
|
0.00%
0/54
|
|
Respiratory, thoracic and mediastinal disorders
Dry Throat
|
1.8%
1/56
|
1.9%
1/53
|
0.00%
0/55
|
0.00%
0/54
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.8%
1/56
|
0.00%
0/53
|
0.00%
0/55
|
0.00%
0/54
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
1.8%
1/56
|
1.9%
1/53
|
3.6%
2/55
|
3.7%
2/54
|
|
Skin and subcutaneous tissue disorders
Cold Sweat
|
0.00%
0/56
|
0.00%
0/53
|
1.8%
1/55
|
0.00%
0/54
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
1.8%
1/56
|
0.00%
0/53
|
0.00%
0/55
|
0.00%
0/54
|
|
Skin and subcutaneous tissue disorders
Pruritus Generalised
|
0.00%
0/56
|
1.9%
1/53
|
0.00%
0/55
|
0.00%
0/54
|
|
Vascular disorders
Hot Flush
|
0.00%
0/56
|
0.00%
0/53
|
1.8%
1/55
|
0.00%
0/54
|
Additional Information
Grace Wang, MD Director Clinical Development & Medical Monitor
Jazz Pharmaceuticals, Inc.
Phone: 650-496-3777
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER