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| ID | Type | Description | Link |
|---|---|---|---|
| R34HL109462 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP+CC | Active Comparator | Continuous Positive Airway Pressure (CPAP) therapy for sleep apnea and contact control (CC) (placebo/sham for cognitive-behavioral therapy for insomnia) |
|
| sham CPAP+CC | Sham Comparator | sham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia) |
|
| CPAP+CBT | Active Comparator | CPAP therapy for sleep apnea and cognitive-behavioral therapy (CBT) for insomnia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP | Device | Treatment for sleep apnea |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Between Baseline and Day 42. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | CPAP+CBT | CPAP therapy for sleep apnea and cognitive-behavioral therapy for insomnia CPAP: Treatment for sleep apnea CBT: Treatment for insomnia |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Sham CPAP+CC |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Study participants who completed protocol | Posted | Mean | Standard Deviation | score on a scale | Between Baseline and Day 42. |
|
3 months
We used the clinical trials website definitions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Kidney problems | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment | Subject was hospitalized for transient kidney problems |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | medDRA 10.0 | Non-systematic Assessment | Recurrent paroxysmal atrial fibrillation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nalaka Gooneratne | University of Pennsylvania | 215 573 2048 | ngoonera@upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 11, 2011 | Aug 28, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D011175 | Positive-Pressure Respiration |
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| CBT | Behavioral | Treatment for insomnia |
|
|
| sham CPAP | Device | Placebo for sleep apnea |
|
|
| CC | Behavioral | Placebo (sham) for insomnia |
|
|
| Ineligible post randomization&screening |
|
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
| BG002 | CPAP+CBT | CPAP therapy for sleep apnea and cognitive-behavioral therapy for insomnia CPAP: Treatment for sleep apnea CBT: Treatment for insomnia |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Insomnia Severity Index | 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. | Mean | Standard Deviation | units on a scale |
|
| 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 |
| OG002 | CPAP+CBT | CPAP therapy for sleep apnea and cognitive-behavioral therapy for insomnia CPAP: Treatment for sleep apnea CBT: Treatment for insomnia |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 4 |
| 17 |
| EG001 | 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 | 0 | 13 | 2 | 13 | 1 | 13 |
| EG002 | CPAP+CBT | CPAP therapy for sleep apnea and cognitive-behavioral therapy for insomnia CPAP: Treatment for sleep apnea CBT: Treatment for insomnia | 0 | 15 | 0 | 15 | 1 | 15 |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment | Admitted for diarrhea; resolved and discharged within 1 day. Subject had two episodes, so two serious adverse events reported |
|
|
| Sinus infection | Infections and infestations | medDRA 10.0 | Non-systematic Assessment | Sinus infection |
|
| Ear ache | Ear and labyrinth disorders | medDRA 10.0 | Non-systematic Assessment | Ear ache |
|
| Mouth pain | General disorders | medDRA 10.0 | Non-systematic Assessment | Mouth pain |
|
| Dizziness | Nervous system disorders | medDRA 10.0 | Non-systematic Assessment | Dizziness |
|
| Neck pain | Musculoskeletal and connective tissue disorders | medDRA 10.0 | Non-systematic Assessment | Neck pain |
|
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |