Study Summary
This trial will compare three treatments for insomnia in patients who have been diagnosed with and treated for sleep apnea: online cognitive behavioral therapy (OCBT), therapist-directed cognitive behavioral therapy (TCBT), and standard clinical care.
Eligible Conditions
- Primary Insomnia
- Obstructive Sleep Apnea
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 3 Secondary · Reporting Duration: Adherence data will be collected through study completion, an average of one year.
Adherence data will be collected through study completion, an average of one year.
Positive Airway Pressure (PAP) Therapy Adherence
Week 1
Quebec Sleep Questionnaire (QSQ) score change
Month 9
Change in subjective measurement of sleep efficiency
Change in subjective measurement of total sleep time
Week 28
Insomnia Severity Index (ISI) score change
Trial Safety
Trial Design
2 Treatment Groups
Standard Care
1 of 2
Intervention
1 of 2
Active Control
Experimental Treatment
384 Total Participants · 2 Treatment Groups
Primary Treatment: Therapist-directed Cognitive Behavioral Therapy (TCBT) · No Placebo Group · N/A
InterventionExperimental Group · 2 Interventions: Online Cognitive Behavioral Therapy (OCBT), Therapist-directed Cognitive Behavioral Therapy (TCBT) · Intervention Types: Behavioral, Behavioral
Standard CareNoIntervention Group · 1 Intervention: Standard Care · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: adherence data will be collected through study completion, an average of one year.
Who is running the clinical trial?
Stanford UniversityOTHER
2,170 Previous Clinical Trials
35,767,899 Total Patients Enrolled
National Jewish HealthLead Sponsor
135 Previous Clinical Trials
317,930 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have persistent sleep onset or sleep maintenance difficulties despite having adequate opportunity for sleep and accompanied by significant daytime impairment or distress about poor sleep.
You have a sleep onset latency or wake time after sleep onset > 30 minutes 3 or more nights per week during two weeks of sleep diary monitoring.
References
- Eldridge-Smith ED, Manber R, Tsai S, Kushida C, Simmons B, Johnson R, Horberg R, Depew A, Abraibesh A, Simpson N, Strand M, Espie CA, Edinger JD. Stepped care management of insomnia co-occurring with sleep apnea: the AIR study protocol. Trials. 2022 Sep 24;23(1):806. doi: 10.1186/s13063-022-06753-4.
- 2017. "Therapist-Directed VS Online Therapy for Insomnia Co-Occuring With Sleep Apnea". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03109210.
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Conditions
Cancer Related
Treatments