Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-01-09 @ 3:15 PM
Study NCT ID:
NCT02552303
Status:
COMPLETED
Last Update Posted:
2017-07-31
First Post:
2015-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Treatment of Insomnia Comorbid With Sleep Disordered Breathing Using Armodafinil and/or Cognitive Behavioral Therapy for Insomnia
Sponsor:
University of Pennsylvania
Organization:
Study Overview
Official Title:
The Treatment of Insomnia Comorbid With Sleep Disordered Breathing Using Armodafinil and/or Cognitive Behavioral Therapy for Insomnia
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the effects of Armodafinil, CBT-I, or the combination of the two on the sleep continuity of persons suffering from sleep disordered breathing and their adherence to CBT-I and Continuous Positive Airway Pressure (CPAP). Adults diagnosed with obstructive sleep apnea and who meet additional research and diagnostic criteria for insomnia will be recruited. Participants will submit daily sleep diaries and supplemental questionnaires as measures of study progress.
Detailed Description:
Rationale:
Insomnia and sleep disordered breathing are the most common sleep disorders and they tend to be highly comorbid. When they co-occur, not only is there an increase in cumulative morbidity, but it is likely that these two diseases interact to: promote overall greater illness severity; reduce treatment adherence; and diminish treatment efficacy. The results from the proposed project will provide valuable information on how co-treatment for these two disorders can promote improved sleep quantity, enhanced sleep quality, better compliance with Positive Airway Pressure (PAP) therapy, and better daytime functioning.
Background:
There is now substantial evidence that Cognitive Behavioral Therapy for Insomnia (CBT-I) is efficacious for Primary Insomnia (PI), that it is as potent as sedative hypnotic treatment, and better sustained over time. Further, there is now increasing evidence that CBT-I can be applied to insomnias that are co-morbid with medical and psychiatric disorders, and with equal efficacy. The evidence for an expanded indication, to date, has been for insomnia comorbid with depression, chronic pain, and cancer. Interestingly, there are very few studies on the efficacy of CBT-I in insomnia comorbid with other intrinsic sleep disorders, including in patients with Sleep Disordered Breathing (SDB). This is surprising given that insomnia frequently occurs comorbidly with SDB. It is estimated that 40-60% of patients with SDB also suffer from insomnia. The lack of data regarding the applicability of CBT-I to insomnia co-morbid with SDB is likely due to the concern that CBT-I will be difficult to tolerate in patients with insomnia co-morbid with SDB given the treatment's tendency to produce acute increases in fatigue, sleepiness, and transient reductions in attention and performance. Accordingly, the investigators of this study propose to conduct a randomized, controlled trial on the effects of Armodafinil alone and in combination with CBT-I in patients with Insomnia comorbid with SDB.
Note: The choice to evaluate Armodafinil as both a monotherapy and an adjuvant therapy to CBT-I for insomnia has a firm conceptual basis and is supported by preliminary data from our group. The choice to evaluate Armodafinil in patients with insomnia co-morbid with SDB is further supported by the existing indication for sleepiness in patients with SDB.
Insomnia and sleep disordered breathing are the most common sleep disorders and they tend to be highly comorbid. When they co-occur, not only is there an increase in cumulative morbidity, but it is likely that these two diseases interact to: promote overall greater illness severity; reduce treatment adherence; and diminish treatment efficacy. The results from the proposed project will provide valuable information on how co-treatment for these two disorders can promote improved sleep quantity, enhanced sleep quality, better compliance with Positive Airway Pressure (PAP) therapy, and better daytime functioning.
Background:
There is now substantial evidence that Cognitive Behavioral Therapy for Insomnia (CBT-I) is efficacious for Primary Insomnia (PI), that it is as potent as sedative hypnotic treatment, and better sustained over time. Further, there is now increasing evidence that CBT-I can be applied to insomnias that are co-morbid with medical and psychiatric disorders, and with equal efficacy. The evidence for an expanded indication, to date, has been for insomnia comorbid with depression, chronic pain, and cancer. Interestingly, there are very few studies on the efficacy of CBT-I in insomnia comorbid with other intrinsic sleep disorders, including in patients with Sleep Disordered Breathing (SDB). This is surprising given that insomnia frequently occurs comorbidly with SDB. It is estimated that 40-60% of patients with SDB also suffer from insomnia. The lack of data regarding the applicability of CBT-I to insomnia co-morbid with SDB is likely due to the concern that CBT-I will be difficult to tolerate in patients with insomnia co-morbid with SDB given the treatment's tendency to produce acute increases in fatigue, sleepiness, and transient reductions in attention and performance. Accordingly, the investigators of this study propose to conduct a randomized, controlled trial on the effects of Armodafinil alone and in combination with CBT-I in patients with Insomnia comorbid with SDB.
Note: The choice to evaluate Armodafinil as both a monotherapy and an adjuvant therapy to CBT-I for insomnia has a firm conceptual basis and is supported by preliminary data from our group. The choice to evaluate Armodafinil in patients with insomnia co-morbid with SDB is further supported by the existing indication for sleepiness in patients with SDB.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: