Therapist-Directed VS Online Therapy for Insomnia Co-Occuring With Sleep Apnea

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sleep Apnea, Obstructive; Insomnia, Primary
• Intervention / Treatment: Behavioral: Online Cognitive Behavioral Therapy (OCBT); Behavioral: Therapist-directed Cognitive Behavioral Therapy (TCBT)

Detailed Description

This dual-site randomized clinical trial will use a "SMART" design to test a stepped care model relative to standard positive airway pressure (PAP) therapy and determine if (1) augmentation of PAP therapy with online Cognitive Behavioral Therapy improves short-term outcomes of comorbid obstructive sleep apnea(OSA)/insomnia; and (2) providing a higher intensity 2nd-stage cognitive behavioral therapy (CBT) to patients who show sub-optimal short-term outcomes with OCBT+PAP improves short and longer-term outcomes. After completing baseline assessment, the 384 comorbid OSA\insomnia patients enrolled will be randomized to a 1st-stage therapy that includes usual care PAP + OCBT (n=288) or UC (usual care PAP + sleep hygiene education; n=96). Insomnia and OSA will be reassessed after 8 weeks. OCBT recipients who meet "remission" criteria will continue PAP but be offered no additional insomnia intervention and will complete study outcome measures again after an additional 8-weeks and at 3 and 6 month follow-ups. OCBT recipients classified as "unremitted" after 8 weeks of treatment will be re-randomized to a 2nd-stage treatment consisting of continued, expanded engagement in OCBT or a switch to therapist-directed CBT (TCBT). Those receiving the 2nd-stage intervention as well as the UC group will be reassessed after another 8 weeks and at 3- and 6-month follow-up time points.

• Study Type: Interventional
• Enrollment (Estimated): 384
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel Johnson, MA; Phone Number: 303-398-1058; Email: johnsonr@njhealth.org

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford Univeristy
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

To be included participants must > 21 years old and:

1. have a diagnosis of OSA with an AHI > 5 on a diagnostic polysomnogram;
2. 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;
3. 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;
4. an Insomnia Severity Index (ISI) score > 10 indicating at least "mild" insomnia; and
5. 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:

1. 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;
2. a lifetime diagnosis of any psychotic or bipolar disorder as sleep restriction for insomnia may precipitate hallucinations and mania;
3. an imminent risk for suicide;
4. alcohol or drug abuse within the past year;
5. terminal illness (e.g., cancer), or neurological degenerative disease (e.g., dementia);
6. current use of medications known to cause insomnia (e.g., stimulants);
7. 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
8. consuming > 2 alcoholic beverages per day on a regular basis; or
9. consuming more than 10 caffeinated beverages per day on a regular basis; or
10. consuming marijuana in any form on a regular basis >1 time per week, or if used after 4:00 p.m; or
11. change in thyroid medication dosage or received a new prescription for thyroid medication 3 months before the screening visit; or
12. physician-diagnosed or self-reported seizure disorder.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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).	Behavioral: Online Cognitive Behavioral Therapy (OCBT); Cognitive behavioral therapy delivered via commercial online software.; Other Names: OCBT; Behavioral: Therapist-directed Cognitive Behavioral Therapy (TCBT); Cognitive Behavioral Therapy delivered via traditional, in-person interaction with a licensed mental health professional.; Other Names: TCBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in subjective measurement of total sleep 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.	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 fill out a sleep diary throughout the study. Study personnel will use these diaries to calculate subjective assessment 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	Participants' adherence to PAP therapy will be passively monitored during their participation in the study.	Adherence data will be collected through study completion, an average of one year.

Collaborators and Investigators

• Sponsor: National Jewish Health
• Collaborators: Stanford University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2017
• Primary Completion (Actual): April 14, 2022
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Initiation and Maintenance Disorders; Apnea
• Other Study ID Numbers: HS2989

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No