Sleep Apnea Syndromes, Sleep Initiation and Maintenance Disorders
Conditions
Brief summary
Nearly half of all patients with obstructive sleep apnea have insomnia symptoms, and in some, but not all cases, these insomnia symptoms are caused by the obstructive sleep apnea. The purpose of this study is to find out what type of insomnia symptoms are caused by obstructive sleep apnea and therefore most likely to respond to obstructive sleep apnea treatment with continuous positive airway pressure (also known as CPAP) and if additional treatment with cognitive-behavioral therapy for insomnia is beneficial.
Interventions
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Sleep Apnea 2. Insomnia 3. Age \>18
Exclusion criteria
1. Sedative/psychoactive drug use recently 2. Other clinically significant sleep disorders 3. Previous treatment for obstructive sleep apnea (OSA) 4. Requires oxygen or bilevel PAP therapy 5. Clinically unstable medical condition 6. Recent shift work 7. Significant alcohol use 8. Other clinically significant causes of insomnia 9. Illicit drug use 10. Prescription stimulants 11. Safety restrictions 12. Unable to treat sleep apnea with positive airway pressure therapy 13. Communication barriers 14. Cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index Score | Between Baseline and Day 42. | Insomnia Severity Index. Minimum: 0. Maximum: 28. Higher scores mean worse outcome. The outcome measure is reported as a change score in which the score at baseline is subtracted from the score at follow-up, thus the more negative the score, the larger the improvement. The total score represents an addition of the questions totals; there is no specific subscale modification required to calculate the total score. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CPAP+CC CPAP therapy for sleep apnea and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)
CPAP: Treatment for sleep apnea
CC: Placebo (sham) for insomnia | 17 |
| Sham CPAP+CC sham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)
sham CPAP: Placebo for sleep apnea
CC: Placebo (sham) for insomnia | 13 |
| CPAP+CBT CPAP therapy for sleep apnea and cognitive-behavioral therapy for insomnia
CPAP: Treatment for sleep apnea
CBT: Treatment for insomnia | 15 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Ineligible post randomization&screening | 0 | 2 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 5 | 3 |
Baseline characteristics
| Characteristic | CPAP+CC | Total | CPAP+CBT | Sham CPAP+CC |
|---|---|---|---|---|
| Age, Continuous | 46.9 years STANDARD_DEVIATION 11.1 | 48.2 years STANDARD_DEVIATION 12.9 | 48.5 years STANDARD_DEVIATION 14.6 | 49.4 years STANDARD_DEVIATION 14.6 |
| Insomnia Severity Index | 22.4 units on a scale STANDARD_DEVIATION 3.5 | 21.9 units on a scale STANDARD_DEVIATION 3.2 | 21.4 units on a scale STANDARD_DEVIATION 3 | 22.2 units on a scale STANDARD_DEVIATION 3.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 22 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 18 Participants | 8 Participants | 5 Participants |
| Sex: Female, Male Female | 9 Participants | 22 Participants | 8 Participants | 5 Participants |
| Sex: Female, Male Male | 8 Participants | 23 Participants | 7 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 13 | 0 / 15 |
| other Total, other adverse events | 4 / 17 | 1 / 13 | 1 / 15 |
| serious Total, serious adverse events | 0 / 17 | 2 / 13 | 0 / 15 |
Outcome results
Primary
Insomnia Severity Index Score
Insomnia Severity Index. Minimum: 0. Maximum: 28. Higher scores mean worse outcome. The outcome measure is reported as a change score in which the score at baseline is subtracted from the score at follow-up, thus the more negative the score, the larger the improvement. The total score represents an addition of the questions totals; there is no specific subscale modification required to calculate the total score.
Time frame: Between Baseline and Day 42.
Population: Study participants who completed protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CPAP+CC | Insomnia Severity Index Score | -8.2 score on a scale | Standard Deviation 6.49 |
| Sham CPAP+CC | Insomnia Severity Index Score | -7.33 score on a scale | Standard Deviation 7.28 |
| CPAP+CBT | Insomnia Severity Index Score | -6.27 score on a scale | Standard Deviation 5.9 |
p-value: 0.8Kruskal-Wallis