A Randomized Cross Over Trial of Two Treatments for Sleep Apnea in Veterans With Post-Traumatic Stress Disorder

NCT01569022 | Completed Results FDA Device

• 1 other identifier: CLIN-005-11F
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep disturbances are cardinal features of Veterans with post traumatic stress disorder (PTSD). In particular, obstructive sleep apnea is reported to occur more frequently in patients with PTSD compared to those without PTSD and contribute to worsening cognitive and behavioral functions. Continuous positive airway pressure (CPAP) is considered the treatment of choice for OSA but adherence to CPAP in Veterans with PTSD is poor compared to the general population. The proposed study aims at comparing the efficacy, tolerability, and adherence of oral appliances-an alternative therapy to OSA- to CPAP. The study is instrumental in identifying the optimal OSA therapy for Veterans with PTSD and the OSA phenotype that would predict oral appliance response

Conditions

Obstructive Sleep Apnea

Keywords

post traumatic stress disorder; continuous positive airway pressure; oral appliance

Outcome Measures

Primary Outcomes (1)

• Residual Apnea Hypopnea Index

  The primary endpoint of the study was tested by comparing the upper limit of the 95% confidence interval for the CPAP-MAD difference in residual AHI with the a priori noninferiority margin using the paired t test

  up to 12 weeks

Secondary Outcomes (3)

• Health Outcomes

  12 weeks

• General Health SF-36

  12 weeks

• Adherence to Therapy

  12 weeks

Study Arms (2)

CPAP First, MAD

ACTIVE COMPARATOR

CPAP treatment for sleep apnea CPAP: CPAP Treatment for 12 weeks MAD: MAD treatment for 12 weeks

Device: CPAP; Device: MAD

MAD First, CPAP

EXPERIMENTAL

MAD treatment for sleep apnea MAD: MAD Treatment for 12 weeks CPAP: CPAP treatment for 12 weeks

Device: CPAP; Device: MAD

Interventions

CPAP DEVICE

CPAP Treatment for 12 weeks

CPAP First, MAD; MAD First, CPAP

MAD DEVICE

MAD Treatment for 12 weeks

CPAP First, MAD; MAD First, CPAP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive patients aged 18-70 years of age
• Documented obstructive sleep apnea by polysomnography (AHI 5 or more/hr)
• Established diagnosis of PTSD related to any past lifetime traumatic event and have a diagnosis of current, chronic PTSD

You may not qualify if:

• Central sleep apnea defined as central apnea/hypopnea \>50% of the total respiratory events
• Prior treatment for sleep apnea
• Veterans with fewer than 4 teeth remaining in either arch
• Coexisting narcolepsy
• Tempo-mandibular joint disease
• Epilepsy
• Prominent suicidal or homicidal ideation
• Diagnosis of dementia

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Western New York Healthcare System, Buffalo, NY

Buffalo, New York, 14215, United States

Location

Related Publications (1)

• El-Solh AA, Homish GG, Ditursi G, Lazarus J, Rao N, Adamo D, Kufel T. A Randomized Crossover Trial Evaluating Continuous Positive Airway Pressure Versus Mandibular Advancement Device on Health Outcomes in Veterans With Posttraumatic Stress Disorder. J Clin Sleep Med. 2017 Nov 15;13(11):1327-1335. doi: 10.5664/jcsm.6808.

  PMID: 29065960 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Ali El Solh
• Organization: VA Western New York

ali.el-solh@va.gov

716-862-6525

Study Officials

• Ali A El-Solh, MD MPH

  VA Western New York Healthcare System, Buffalo, NY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: randomized trial

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: April 2, 2012
• Study Start: November 1, 2012
• Primary Completion: October 30, 2016
• Study Completion: March 30, 2017
• Last Updated: November 8, 2017
• Results First Posted: November 8, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)