NCT02027558

Brief 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 sleep and PAP adherence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2013

Completed
21 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 3, 2019

Completed
Last Updated

June 3, 2019

Status Verified

February 1, 2019

Enrollment Period

3.7 years

First QC Date

December 11, 2013

Results QC Date

September 26, 2018

Last Update Submit

February 22, 2019

Conditions

InsomniaApnea

Keywords

cognitive behavioral therapyinsomniaapnea

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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.

    Three months after randomization

Study Arms (2)

Behavioral treatment

EXPERIMENTAL

Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions.

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.

Behavioral: General sleep education

Interventions

Insomnia treatment & PAP adherenceBEHAVIORAL

Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions.

Behavioral treatment
General sleep educationBEHAVIORAL

Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions.

Active control

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Significant cognitive impairment (MMSE \< 24)
  • History of mania, major psychopathology or a psychiatric hospitalization in prior two years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Sepulveda, California, 91343, United States

Location

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

Location

Related Publications (2)

  • 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.

    PMID: 27136498RESULT

  • 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.

    PMID: 33221910DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersApnea

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Cathy Alessi, MD
Organization
VA Greater Los Angeles Healthcare System
Cathy.Alessi@va.gov
818-891-7711

Study Officials

  • Cathy Alessi, MD

    VA Greater Los Angeles Healthcare System, Sepulveda, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2013

First Posted

January 6, 2014

Study Start

January 1, 2014

Primary Completion

September 30, 2017

Study Completion

January 31, 2018

Last Updated

June 3, 2019

Results First Posted

June 3, 2019

Record last verified: 2019-02

Locations

US(2)