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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
Conditions the study is for: Insomnia, Apnea
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

Other trials in United States

About this study

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.

Conditions: Insomnia, Apnea
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 groups in NCT02027558
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.

1 Jan 201431 Jan 2018

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)

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 27136498
Alessi 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Insomnia trials

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
Conditions: Insomnia, Apnea
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.

Detailed description

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

Results posted to the registry on 3 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Behavioral Treatment	62	53
Active Control	63	61

Primary outcome: Sleep Quality

Time frame: Three months after randomization. Mean (Standard Error). Unit: score on a scale

Measure	Behavioral Treatment n = 62	Active Control n = 63
Value	6.25 (0.56)	9.87 (0.53)

Behavioral Treatment vs Active Control: Mean Difference (Net): -3.21 (95% CI -4.58 to -1.83), p <.001, Mixed Models Analysis

Primary outcome: Sleep Onset Latency From Sleep Diary

Time frame: Three months after randomization. Mean (Standard Error). Unit: minutes

Measure	Behavioral Treatment n = 62	Active Control n = 63
Value	22.80 (3.86)	35.77 (3.74)

Behavioral Treatment vs Active Control: Mean Difference (Net): -16.23 (95% CI -29.02 to -2.49), p = 0.013, Mixed Models Analysis

Primary outcome: Wake After Sleep Onset From Sleep Diary

Time frame: Three months after randomization. Mean (Standard Error). Unit: minutes

Measure	Behavioral Treatment n = 62	Active Control n = 63
Value	20.42 (4.31)	40.67 (4.16)

Behavioral Treatment vs Active Control: Mean Difference (Net): -20.46 (95% CI -37.63 to -3.29), p = 0.019, Mixed Models Analysis

Primary outcome: Sleep Efficiency From Sleep Diary

Time frame: Three months after randomization. Mean (Standard Error). Unit: percentage of time

Measure	Behavioral Treatment n = 62	Active Control n = 63
Value	86.24 (1.69)	75.69 (1.64)

Behavioral Treatment vs Active Control: Mean Difference (Net): 10.49 (95% CI 4.53 to 16.44), p = 0.001, Mixed Models Analysis

Adverse events

Time frame: Adverse event data were collected for 6 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Behavioral Treatment	0 of 62 (0%)	1 of 62 (1.6%)	0 of 62
Active Control	0 of 63 (0%)	0 of 63 (0%)	1 of 63

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

Related trials for Insomnia

Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
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Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
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Recruiting
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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.