InsomniaNCT02027558
Novel Treatment of Comorbid Insomnia and Sleep Apnea in Older Veterans
A study testing Insomnia treatment & PAP adherence and General sleep education in people with Insomnia and Apnea, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether a novel intervention combining cognitive behavioral therapy for insomnia plus a positive airway pressure (PAP) behavioral adherence program provided by allied health personnel for older Veterans with obstructive sleep apnea and comorbid insomnia improves nighttime… Read more about this study
- Who is it for?
- Ages 50 years and older
- What is being tested?
- Insomnia treatment & PAP adherence and General sleep education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2014to 31 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets diagnostic criteria for insomnia
- Diagnosis of obstructive sleep apnea (AHI > or = 15) and prescription of PAP therapy
- Age > or =50
- Community-dwelling
- Live within a 30-mile radius of VA GLAHS
- Have transportation to VA GLAHS to attend the intervention/control programs
Who cannot join
- Significant cognitive impairment (MMSE < 24)
- History of mania, major psychopathology or a psychiatric hospitalization in prior two years
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, 91343
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073
About this study
The purpose of this study is to determine whether a novel intervention combining cognitive behavioral therapy for insomnia plus a positive airway pressure (PAP) behavioral adherence program provided by allied health personnel for older Veterans with obstructive sleep apnea and comorbid insomnia improves nighttime sleep and PAP adherence.
Read the detailed description
Sleep disturbance is common in older adults and is associated with increased healthcare utilization, more depressive symptoms, and other adverse effects on health-related quality of life. Obstructive sleep apnea (OSA) is a disorder characterized by repetitive episodes of complete or partial upper airway obstruction occurring during sleep. OSA increases in prevalence with age, and is associated with increased risk of cardiovascular disease, decreased quality of life, and increased mortality. Insomnia also increases in prevalence with age, and is associated with numerous adverse outcomes, including cognitive decline, decreased quality of life, increased healthcare costs and increased mortality. The diagnostic criteria for insomnia include a decreased ability to fall asleep or stay asleep, frequent nighttime awakening or poor quality sleep that is associated with daytime impairment such as fatigue, impaired attention, or daytime sleepiness. Increasing evidence suggests that insomnia often coexists with OSA, particularly in older adults, and predicts worse outcomes of OSA. Both OSA and insomnia have a higher prevalence among Veterans, compared to the general population.
Little is known of the best approaches to manage the large number of patients with coexisting OSA and comorbid insomnia. Guidelines for best practice typically address these conditions separately, where positive airway pressure (PAP) is the standard for the treatment of OSA, and cognitive behavioral therapy for insomnia (CBT-I) is considered first-line treatment for chronic insomnia. CBT-I is particularly recommended for insomnia in older adults, where adverse effects of sleeping medications are most problematic. Early adherence to PAP therapy (i.e., within the first week of PAP therapy) is one of the strongest predictors of long-term PAP adherence. However, adherence rates to PAP therapy in patients with OSA are low. In addition, CBT-I has not been widely implemented for treatment of insomnia (in part due to limited access to mental health specialists able to provide CBT-I), untreated OSA limits response to treatment of insomnia, and untreated insomnia negatively impacts PAP adherence.
Based on this evidence and findings from the investigators' prior work, the investigators believe that an integrated, behavioral treatment approach which addresses both OSA and insomnia early in the course of PAP therapy is needed to maximize patient adherence and treatment success when these conditions coexist. The investigators propose a randomized controlled trial to test a novel, behavioral approach integrating best practices for management of both conditions among older Veterans with OSA who are prescribed PAP therapy and have comorbid insomnia. The purpose of this project is to determine whether this intervention improves nighttime sleep and PAP adherence.
- Being tested
- Insomnia treatment & PAP adherence, General sleep education
- Keywords
- cognitive behavioral therapy, insomnia, apnea
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insomnia treatment & PAP adherenceBehavioural
Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions.
General sleep educationBehavioural
Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral treatment | Experimental | Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions. Receives: Behavioral: Insomnia treatment & PAP adherence |
| Active control | Active comparator | Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions. Receives: Behavioral: General sleep education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
Total score on the Pittsburgh Sleep Quality Index will be used as a measure of sleep quality. Scores range from 0 to 21. Higher scores indicate worse outcome.
Measured: Three months after randomization
Sleep Onset Latency From Sleep Diary
Sleep onset latency (minutes to fall asleep) will be calculated from 7 days of self-reported sleep diary. Minimum value is 0 minutes. Maximum possible value is 1,440 minutes (24 hours). Higher scores indicate worse outcome.
Measured: Three months after randomization
Wake After Sleep Onset From Sleep Diary
Wake after sleep onset (minutes awake from sleep onset to get up time) will be calculated from 7 days of self-reported sleep diary. Minimum value is 0 minutes. Maximum possible value is 1,440 minutes (24 hours). Higher scores indicate worse outcome.
Measured: Three months after randomization
Sleep Efficiency From Sleep Diary
Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of self-reported sleep diary. Scores range from 0 to 100 percent. Higher scores indicate better outcome.
Measured: Three months after randomization
Sleep Efficiency From Wrist Actigraphy
Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of wrist actigraphy. Scores range from 0 to 100 percent. Higher scores indicate better outcome.
Measured: Three months after randomization
PAP Adherence
Number of nights positive airway pressure (PAP) was used >=4 hours during the first 90 days measured by remote monitoring. Scores range from 0 to 90 days. Higher scores indicate better outcome.
Measured: Three months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study start1 Jan 2014
- Primary completion30 Sep 2017
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Cathy Alessi, MD, Principal investigator, VA Greater Los Angeles Healthcare System, Sepulveda, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027558
- Sponsor's protocol ID
- IIR 12-353
- Status last verified
- Feb 2019
- First submitted
- 11 Dec 2013
- Last updated
- 3 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fung CH, Martin JL, Josephson K, Fiorentino L, Dzierzewski JM, Jouldjian S, Tapia JC, Mitchell MN, Alessi C. Efficacy of Cognitive Behavioral Therapy for Insomnia in Older Adults With Occult Sleep-Disordered Breathing. Psychosom Med. 2016 Jun;78(5):629-39. doi: 10.1097/PSY.0000000000000314.
PubMed 27136498Alessi CA, Fung CH, Dzierzewski JM, Fiorentino L, Stepnowsky C, Rodriguez Tapia JC, Song Y, Zeidler MR, Josephson K, Mitchell MN, Jouldjian S, Martin JL. Randomized controlled trial of an integrated approach to treating insomnia and improving the use of positive airway pressure therapy in veterans with comorbid insomnia disorder and obstructive sleep apnea. Sleep. 2021 Apr 9;44(4):zsaa235. doi: 10.1093/sleep/zsaa235.
PubMed 33221910
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Treatment of Comorbid Insomnia and Sleep Apnea in Older Veterans
- ClinicalTrials.gov ID
- NCT02027558
- Acronym / sponsor ID
- IIR 12-353
- Keywords
- cognitive behavioral therapy, insomnia, apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 6 Jan 2014 (estimated)
- Results
- Posted 3 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a novel intervention combining cognitive behavioral therapy for insomnia plus a positive airway pressure (PAP) behavioral adherence program provided by allied health personnel for older Veterans with obstructive sleep apnea and comorbid insomnia improves nighttime sleep and PAP adherence.
Detailed description
Sleep disturbance is common in older adults and is associated with increased healthcare utilization, more depressive symptoms, and other adverse effects on health-related quality of life. Obstructive sleep apnea (OSA) is a disorder characterized by repetitive episodes of complete or partial upper airway obstruction occurring during sleep. OSA increases in prevalence with age, and is associated with increased risk of cardiovascular disease, decreased quality of life, and increased mortality. Insomnia also increases in prevalence with age, and is associated with numerous adverse outcomes, including cognitive decline, decreased quality of life, increased healthcare costs and increased mortality. The diagnostic criteria for insomnia include a decreased ability to fall asleep or stay asleep, frequent nighttime awakening or poor quality sleep that is associated with daytime impairment such as fatigue, impaired attention, or daytime sleepiness. Increasing evidence suggests that insomnia often coexists with OSA, particularly in older adults, and predicts worse outcomes of OSA. Both OSA and insomnia have a higher prevalence among Veterans, compared to the general population.
Little is known of the best approaches to manage the large number of patients with coexisting OSA and comorbid insomnia. Guidelines for best practice typically address these conditions separately, where positive airway pressure (PAP) is the standard for the treatment of OSA, and cognitive behavioral therapy for insomnia (CBT-I) is considered first-line treatment for chronic insomnia. CBT-I is particularly recommended for insomnia in older adults, where adverse effects of sleeping medications are most problematic. Early adherence to PAP therapy (i.e., within the first week of PAP therapy) is one of the strongest predictors of long-term PAP adherence. However, adherence rates to PAP therapy in patients with OSA are low. In addition, CBT-I has not been widely implemented for treatment of insomnia (in part due to limited access to mental health specialists able to provide CBT-I), untreated OSA limits response to treatment of insomnia, and untreated insomnia negatively impacts PAP adherence.
Based on this evidence and findings from the investigators' prior work, the investigators believe that an integrated, behavioral treatment approach which addresses both OSA and insomnia early in the course of PAP therapy is needed to maximize patient adherence and treatment success when these conditions coexist. The investigators propose a randomized controlled trial to test a novel, behavioral approach integrating best practices for management of both conditions among older Veterans with OSA who are prescribed PAP therapy and have comorbid insomnia. The purpose of this project is to determine whether this intervention improves nighttime sleep and PAP adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral treatment | Experimental | Behavioral: Insomnia treatment & PAP adherenceManual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions. |
| Active control | Active comparator | Behavioral: General sleep educationManual-based non-directive general sleep education program provided by allied health personnel in individual sessions. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meets diagnostic criteria for insomnia
- Diagnosis of obstructive sleep apnea (AHI > or = 15) and prescription of PAP therapy
- Age > or =50
- Community-dwelling
- Live within a 30-mile radius of VA GLAHS
Key exclusion criteria (2 listed)
- Significant cognitive impairment (MMSE < 24)
- History of mania, major psychopathology or a psychiatric hospitalization in prior two years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insomnia treatment & PAP adherenceManual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions. | Behavioural | Behavioral treatment |
| General sleep educationManual-based non-directive general sleep education program provided by allied health personnel in individual sessions. | Behavioural | Active control |
Primary outcome
Sleep Quality
Time frame: Three months after randomization
Total score on the Pittsburgh Sleep Quality Index will be used as a measure of sleep quality. Scores range from 0 to 21. Higher scores indicate worse outcome.
Sleep Onset Latency From Sleep Diary
Time frame: Three months after randomization
Sleep onset latency (minutes to fall asleep) will be calculated from 7 days of self-reported sleep diary. Minimum value is 0 minutes. Maximum possible value is 1,440 minutes (24 hours). Higher scores indicate worse outcome.
Wake After Sleep Onset From Sleep Diary
Time frame: Three months after randomization
Wake after sleep onset (minutes awake from sleep onset to get up time) will be calculated from 7 days of self-reported sleep diary. Minimum value is 0 minutes. Maximum possible value is 1,440 minutes (24 hours). Higher scores indicate worse outcome.
Sleep Efficiency From Sleep Diary
Time frame: Three months after randomization
Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of self-reported sleep diary. Scores range from 0 to 100 percent. Higher scores indicate better outcome.
Sleep Efficiency From Wrist Actigraphy
Time frame: Three months after randomization
Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of wrist actigraphy. Scores range from 0 to 100 percent. Higher scores indicate better outcome.
PAP Adherence
Time frame: Three months after randomization
Number of nights positive airway pressure (PAP) was used >=4 hours during the first 90 days measured by remote monitoring. Scores range from 0 to 90 days. Higher scores indicate better outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27136498Fung CH, Martin JL, Josephson K, Fiorentino L, Dzierzewski JM, Jouldjian S, Tapia JC, Mitchell MN, Alessi C. Efficacy of Cognitive Behavioral Therapy for Insomnia in Older Adults With Occult Sleep-Disordered Breathing. Psychosom Med. 2016 Jun;78(5):629-39. doi: 10.1097/PSY.0000000000000314.
- Derived from this study: PubMed 33221910Alessi CA, Fung CH, Dzierzewski JM, Fiorentino L, Stepnowsky C, Rodriguez Tapia JC, Song Y, Zeidler MR, Josephson K, Mitchell MN, Jouldjian S, Martin JL. Randomized controlled trial of an integrated approach to treating insomnia and improving the use of positive airway pressure therapy in veterans with comorbid insomnia disorder and obstructive sleep apnea. Sleep. 2021 Apr 9;44(4):zsaa235. doi: 10.1093/sleep/zsaa235.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathy Alessi, MD principal investigator
VA Greater Los Angeles Healthcare System, Sepulveda, CA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insomnia treatment & PAP adherence and General sleep education in people with Insomnia and Apnea, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: Three months after randomization). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02027558, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019; AzTrials last refreshed its copy on 7 Nov 2026.