Therapist-Directed VS Online Therapy for Insomnia Co-Occuring With Sleep Apnea
1 other identifier
interventional
384
1 country
2
Brief Summary
This two-site randomized clinical trial will investigate and 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. 384 patients will be recruited and will attend up to 15 visits over 10 months. Visits will include baseline assessment, treatment visits, and post-treatment follow-up visits. Visits will involve completion of questionnaires, meeting with therapists, and a physical exam.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2017
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2017
CompletedFirst Posted
Study publicly available on registry
April 12, 2017
CompletedStudy Start
First participant enrolled
April 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedFebruary 21, 2025
February 1, 2025
5 years
March 27, 2017
February 20, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Insomnia Severity Index (ISI) score change
Change in participants' score on the ISI will be measured over baseline, post-treatment, and follow-up visits.
Symptom remission will be measured at post-treatment visits one and two, approximately 18 and 28 weeks following enrollment.
Quebec Sleep Questionnaire (QSQ) score change
Change in participants' score on the QSQ will be measured over baseline, post-treatment, and follow-up visits.
Participants will be asked to complete the QSQ at baseline, post-treatment, and follow-up visits, at approximately weeks 1, 18, and 28.
Secondary Outcomes (3)
Change in subjective measurement of total sleep time
Participants will be asked to complete two weeks of sleep diaries at baseline (week 1), post-treatment (weeks 8 and 18), and follow-up visits (months 9 and 12) to measure change in these assessments over time.
Change in subjective measurement of sleep efficiency
Participants will be asked to complete two weeks of sleep diaries at baseline (week 1), post-treatment (weeks 8 and 18), and follow-up visits (months 9 and 12) to measure change in these assessments over time.
Positive Airway Pressure (PAP) Therapy Adherence
Adherence data will be collected through study completion, an average of one year.
Study Arms (2)
Standard Care
NO INTERVENTIONParticipants randomized to standard care will receive normal follow-up care with their health care provider. This will include routine assessment and adjustment of PAP therapy, and instruction in proper sleep hygiene.
Intervention
EXPERIMENTALIn addition to standard care procedures, participants randomized to the intervention arm will receive up to two sequential treatments. First, participants will receive Online Cognitive Behavioral Therapy (OCBT). Those who meet criteria for remission after this first treatment will continue through follow-up without further treatment. Those who do not will be randomized again to either extended OCBT, or Therapist-directed Cognitive Behavioral Therapy (TCBT).
Interventions
Cognitive behavioral therapy delivered via commercial online software.
Cognitive Behavioral Therapy delivered via traditional, in-person interaction with a licensed mental health professional.
Eligibility Criteria
You may qualify if:
- To be included participants must \> 21 years old and:
- have a diagnosis of OSA with an AHI \> 5 on a diagnostic polysomnogram;
- accept PAP as primary/sole OSA therapy, been given a prescription for PAP and filled it within the last 3 months, have had an opportunity to use PAP for at least one month, and show mean use of \> 1 hour per night;
- have a complaint of persistent (i.e., \> 3 months) sleep onset or sleep maintenance difficulties despite having adequate opportunity for sleep and accompanied by significant daytime impairment or distress about poor sleep;
- an Insomnia Severity Index (ISI) score \> 10 indicating at least "mild" insomnia; and
- 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.
You may not qualify if:
- an untreated psychiatric disorder (e.g., major depression) found on structured interviews as these conditions have specific treatments and it would be inappropriate not to offer those treatments;
- a lifetime diagnosis of any psychotic or bipolar disorder as sleep restriction for insomnia may precipitate hallucinations and mania;
- an imminent risk for suicide;
- alcohol or drug abuse within the past year;
- terminal illness (e.g., cancer), or neurological degenerative disease (e.g., dementia);
- current use of medications known to cause insomnia (e.g., stimulants);
- comorbid narcolepsy, idiopathic hypersomnia, restless legs syndrome (score of \>11 in the IRLS), periodic limb movement during sleep (known PLMS with arousal \> 15 per hour), or a circadian rhythm sleep disorder if habitual bedtimes are later than 3:00 AM or rising times are later than 11:00 AM; or
- consuming \> 2 alcoholic beverages per day on a regular basis; or
- consuming more than 10 caffeinated beverages per day on a regular basis; or
- consuming marijuana in any form on a regular basis \>1 time per week, or if used after 4:00 p.m; or
- change in thyroid medication dosage or received a new prescription for thyroid medication 3 months before the screening visit; or
- physician-diagnosed or self-reported seizure disorder.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Jewish Healthlead
- Stanford Universitycollaborator
Study Sites (2)
Stanford Univeristy
Palo Alto, California, 94304, United States
National Jewish Health
Denver, Colorado, 80206, United States
Related Publications (1)
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.
PMID: 36153634DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2017
First Posted
April 12, 2017
Study Start
April 15, 2017
Primary Completion
April 14, 2022
Study Completion (Estimated)
June 30, 2026
Last Updated
February 21, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share