Therapist-Directed VS Online Therapy for Insomnia Co-Occuring With Sleep Apnea
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ClinicalTrials.gov Identifier: NCT03109210 |
Recruitment Status :
Recruiting
First Posted : April 12, 2017
Last Update Posted : February 18, 2022
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Condition or disease | Intervention/treatment | Phase |
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Insomnia, Primary Sleep Apnea, Obstructive | Behavioral: Online Cognitive Behavioral Therapy (OCBT) Behavioral: Therapist-directed Cognitive Behavioral Therapy (TCBT) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 384 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Therapist-Directed VS Online Therapy for Insomnia Co-Occuring With Sleep Apnea |
Actual Study Start Date : | April 15, 2017 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | April 14, 2023 |
Arm | Intervention/treatment |
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No Intervention: Standard Care
Participants 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.
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Experimental: Intervention
In 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).
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Behavioral: Online Cognitive Behavioral Therapy (OCBT)
Cognitive behavioral therapy delivered via commercial online software.
Other Name: OCBT Behavioral: Therapist-directed Cognitive Behavioral Therapy (TCBT) Cognitive Behavioral Therapy delivered via traditional, in-person interaction with a licensed mental health professional.
Other Name: TCBT |
- Insomnia Severity Index (ISI) score change [ Time Frame: Symptom remission will be measured at post-treatment visits one and two, approximately 18 and 28 weeks following enrollment. ]Change in participants' score on the ISI will be measured over baseline, post-treatment, and follow-up visits.
- Quebec Sleep Questionnaire (QSQ) score change [ Time Frame: Participants will be asked to complete the QSQ at baseline, post-treatment, and follow-up visits, at approximately weeks 1, 18, and 28. ]Change in participants' score on the QSQ will be measured over baseline, post-treatment, and follow-up visits.
- Change in subjective measurement of total sleep time [ Time Frame: 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. ]Participants will be asked to fill out a sleep diary throughout the study. Study personnel will use these diaries to calculate subjective assessment of total sleep time.
- Change in subjective measurement of sleep efficiency [ Time Frame: 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. ]Participants will be asked to fill out a sleep diary throughout the study. Study personnel will use these diaries to calculate subjective assessment of sleep efficiency.
- Positive Airway Pressure (PAP) Therapy Adherence [ Time Frame: Adherence data will be collected through study completion, an average of one year. ]Participants' adherence to PAP therapy will be passively monitored during their participation in the study.

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109210
Contact: Rachel Johnson, MA | 303-398-1058 | johnsonr@njhealth.org |
United States, California | |
Stanford Univeristy | Recruiting |
Palo Alto, California, United States, 94304 | |
Contact: Bella Scott, BA 650-721-1256 bella09@stanford.edu | |
United States, Colorado | |
National Jewish Health | Recruiting |
Denver, Colorado, United States, 80206 | |
Contact: Bryan Simmons 303-398-1850 simmonsb@njhealth.org | |
Principal Investigator: Jack D Edinger, PhD |
Responsible Party: | National Jewish Health |
ClinicalTrials.gov Identifier: | NCT03109210 |
Other Study ID Numbers: |
HS2989 |
First Posted: | April 12, 2017 Key Record Dates |
Last Update Posted: | February 18, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Initiation and Maintenance Disorders Respiration Disorders Respiratory Tract Diseases |
Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Mental Disorders |