Trial Outcomes & Findings for Apnea, Bariatric Surgery Versus Continuous Positive Airway Pressure (CPAP) Trial (NCT NCT01187771)
NCT ID: NCT01187771
Last Updated: 2019-06-04
Results Overview
The Effective Apnea Hypopnea Index (AHI) is the actual frequency of apneas and hypopneas per hour that the patient is exposed to. It is calculated as the AHI while on CPAP times the proportion of sleep time that CPAP was used plus the AHI off CPAP times the proportion of sleep time that CPAP is not used.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
9 months
Results posted on
2019-06-04
Participant Flow
Between enrollment and assignment, 3 participants withdrew their consent to participate and 1 participant's physician withdrew the determination of eligibility.
Participant milestones
| Measure |
Laparoscopic Gastric Banding
|
Continuous Positive Airway Pressure
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
21
|
|
Overall Study
COMPLETED
|
25
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Apnea, Bariatric Surgery Versus Continuous Positive Airway Pressure (CPAP) Trial
Baseline characteristics by cohort
| Measure |
Laparoscopic Gastric Banding
n=28 Participants
|
Continuous Positive Airway Pressure
n=21 Participants
|
Total
n=49 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
|
28 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
50.7 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
46.3 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
48.8 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
21 participants
n=7 Participants
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 monthsThe Effective Apnea Hypopnea Index (AHI) is the actual frequency of apneas and hypopneas per hour that the patient is exposed to. It is calculated as the AHI while on CPAP times the proportion of sleep time that CPAP was used plus the AHI off CPAP times the proportion of sleep time that CPAP is not used.
Outcome measures
| Measure |
Laparoscopic Gastric Banding
n=25 Participants
|
Continuous Positive Airway Pressure
n=18 Participants
|
|---|---|---|
|
Effective Apnea Hypopnea Index
|
29.5 Events per hour
Standard Deviation 23.4
|
20.0 Events per hour
Standard Deviation 25.3
|
PRIMARY outcome
Timeframe: 9 monthsThe Epworth Sleepiness Scale results in scores ranging from 0-24, where scores of 0-10 indicate normal levels of sleepiness while 11-24 indicate excessive daytime sleepiness.
Outcome measures
| Measure |
Laparoscopic Gastric Banding
n=25 Participants
|
Continuous Positive Airway Pressure
n=18 Participants
|
|---|---|---|
|
Epworth Sleepiness Score
|
7.6 Units on Epworth Sleepiness scale
Standard Deviation 4.7
|
7.8 Units on Epworth Sleepiness scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: 9 monthsOutcome measures
| Measure |
Laparoscopic Gastric Banding
n=25 Participants
|
Continuous Positive Airway Pressure
n=18 Participants
|
|---|---|---|
|
Mean 24-hour Systolic Blood Pressure
|
121.7 mmHg
Standard Deviation 13.0
|
119.5 mmHg
Standard Deviation 16.8
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Data were not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 9 monthsThe Calgary Sleep Apnea Quality of Life Index results in scores ranging from 1-7, with higher scores indicating a higher quality of life.
Outcome measures
| Measure |
Laparoscopic Gastric Banding
n=25 Participants
|
Continuous Positive Airway Pressure
n=18 Participants
|
|---|---|---|
|
Calgary Sleep Apnea Quality of Life Index
|
4.8 Units on Quality of Life Index
Standard Deviation 0.7
|
4.4 Units on Quality of Life Index
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 9 monthsThe PHQ-9 is scored from 0-27 with higher scores indicating more severe depression.
Outcome measures
| Measure |
Laparoscopic Gastric Banding
n=25 Participants
|
Continuous Positive Airway Pressure
n=18 Participants
|
|---|---|---|
|
Depression (Patient Health Questionnaire-9)
|
4.0 PHQ-9 scale
Standard Deviation 3.7
|
6.2 PHQ-9 scale
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 9 monthsOutcome measures
| Measure |
Laparoscopic Gastric Banding
n=25 Participants
|
Continuous Positive Airway Pressure
n=18 Participants
|
|---|---|---|
|
Mean 24-hour Diastolic Blood Pressure
|
75.8 mmHg
Standard Deviation 8.8
|
74.9 mmHg
Standard Deviation 11.0
|
Adverse Events
Laparoscopic Gastric Banding
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
Continuous Positive Airway Pressure
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Laparoscopic Gastric Banding
n=28 participants at risk
|
Continuous Positive Airway Pressure
n=21 participants at risk
|
|---|---|---|
|
Renal and urinary disorders
Renal disorders
|
0.00%
0/28
|
4.8%
1/21
|
|
Renal and urinary disorders
Urinary tract signs and symptoms
|
3.6%
1/28
|
0.00%
0/21
|
|
Psychiatric disorders
Anxiety disorders and symptoms
|
3.6%
1/28
|
0.00%
0/21
|
|
Psychiatric disorders
Suicidal and self-injurious behaviors NEC
|
3.6%
1/28
|
4.8%
1/21
|
|
Gastrointestinal disorders
Gastrointestinal infections
|
3.6%
1/28
|
0.00%
0/21
|
|
Hepatobiliary disorders
Gallbladder disorders
|
3.6%
1/28
|
0.00%
0/21
|
|
Injury, poisoning and procedural complications
Bone and joint injuries
|
0.00%
0/28
|
4.8%
1/21
|
|
Musculoskeletal and connective tissue disorders
Bone disorders (excl congenital and fractures)
|
3.6%
1/28
|
0.00%
0/21
|
Other adverse events
| Measure |
Laparoscopic Gastric Banding
n=28 participants at risk
|
Continuous Positive Airway Pressure
n=21 participants at risk
|
|---|---|---|
|
Cardiac disorders
Coronary artery disrders
|
3.6%
1/28
|
0.00%
0/21
|
|
Ear and labyrinth disorders
Aural disorders NEC
|
14.3%
4/28
|
9.5%
2/21
|
|
Eye disorders
Ocular infections, irritations and inflammations
|
3.6%
1/28
|
0.00%
0/21
|
|
Gastrointestinal disorders
Diverticular disorders
|
3.6%
1/28
|
4.8%
1/21
|
|
Hepatobiliary disorders
Gallbladder disorders
|
7.1%
2/28
|
0.00%
0/21
|
|
Gastrointestinal disorders
Gastrointestinal infections
|
3.6%
1/28
|
0.00%
0/21
|
|
Gastrointestinal disorders
Gastrointestinal motility
|
3.6%
1/28
|
0.00%
0/21
|
|
Gastrointestinal disorders
Gastrointestinal signs and symptoms
|
10.7%
3/28
|
9.5%
2/21
|
|
Gastrointestinal disorders
Dental and gingival conditions
|
0.00%
0/28
|
4.8%
1/21
|
|
General disorders
Drowsy driving
|
21.4%
6/28
|
14.3%
3/21
|
|
Nervous system disorders
Headaches
|
7.1%
2/28
|
4.8%
1/21
|
|
Injury, poisoning and procedural complications
Bone and joint injuries
|
3.6%
1/28
|
9.5%
2/21
|
|
Injury, poisoning and procedural complications
Injuries NEC
|
17.9%
5/28
|
19.0%
4/21
|
|
Injury, poisoning and procedural complications
Medication errors
|
3.6%
1/28
|
0.00%
0/21
|
|
Injury, poisoning and procedural complications
Procedural related injuries and complicatins NEC
|
3.6%
1/28
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Glucose metabolism disorders
|
3.6%
1/28
|
4.8%
1/21
|
|
Musculoskeletal and connective tissue disorders
Bone disorders (excl congenital and fractures)
|
3.6%
1/28
|
4.8%
1/21
|
|
Musculoskeletal and connective tissue disorders
Joint disorders
|
10.7%
3/28
|
14.3%
3/21
|
|
Musculoskeletal and connective tissue disorders
Muscle disorders
|
3.6%
1/28
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders NEC
|
3.6%
1/28
|
14.3%
3/21
|
|
Musculoskeletal and connective tissue disorders
Tendon, ligament and cartilage disorders
|
7.1%
2/28
|
0.00%
0/21
|
|
Nervous system disorders
Demyelinating disorders
|
3.6%
1/28
|
0.00%
0/21
|
|
Nervous system disorders
Movement disorders
|
0.00%
0/28
|
4.8%
1/21
|
|
Psychiatric disorders
Anxiety disorders and symptoms
|
0.00%
0/28
|
9.5%
2/21
|
|
Psychiatric disorders
Depressed mood disorders and disturbances
|
3.6%
1/28
|
14.3%
3/21
|
|
Psychiatric disorders
Mental impairment disorders
|
0.00%
0/28
|
4.8%
1/21
|
|
Psychiatric disorders
Mood disorders and disturbances NEC
|
3.6%
1/28
|
0.00%
0/21
|
|
Renal and urinary disorders
Bladder and bladder neck disorders (excl calculi)
|
0.00%
0/28
|
4.8%
1/21
|
|
Renal and urinary disorders
Genitourinary tract disorders NEC
|
3.6%
1/28
|
0.00%
0/21
|
|
Renal and urinary disorders
Urolithiases
|
0.00%
0/28
|
9.5%
2/21
|
|
Reproductive system and breast disorders
Female reproductive tract infections and inflammations
|
7.1%
2/28
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorders NEC
|
7.1%
2/28
|
4.8%
1/21
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infections
|
32.1%
9/28
|
42.9%
9/21
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract disorders (excl infections)
|
7.1%
2/28
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Epidermal and dermal conditions
|
14.3%
4/28
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue infections and infestations
|
3.6%
1/28
|
0.00%
0/21
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place