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A randomized, placebo-controlled trial using a novel PAP delivery platform to treat patients with OSA and comorbid PTSD

  • Sleep Breathing Physiology and Disorders • Original Article
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Abstract

Purpose

Positive airway pressure (PAP) adherence is poor in comorbid OSA/PTSD. SensAwake™ (SA) is a wake-sensing PAP algorithm that lowers pressure when wake is detected. We compared auto-PAP (aPAP) with and without SA for comorbid OSA/PTSD.

Methods

Prospective, randomized crossover study comparing aPAP to aPAP + SA. We enrolled patients with OSA/PTSD who were PAP naïve. Four weeks after randomization, the patients were crossed over to the alternate treatment group, with final follow-up at eight weeks. Sleep questionnaires (ESS, ISI, FSS, and FOSQ-10) were assessed at baseline and follow-up.

Results

We enrolled 85 patients with OSA/PTSD. aPAP reduced AHI to < 5/h in both groups. Our primary endpoint, average hours of aPAP adherence (total) after 4 weeks, was significantly increased in the SA group in our intention-to-treat (ITT) analysis (ß = 1.13 (95% CI 0.16–2.1); p = 0.02), after adjustment for ESS differences at baseline. After adjustment for ESS, SA (ITT analysis) also showed significant improvement in percentage of nights used for ≥ 4 h (ß = 14.9 (95% CI 1.02–28.9); p = 0.04). There were trends toward an increase in percentage nights used total (ß = 17.4 (95% CI − 0.1 to 34.9); p = 0.05), average hours of aPAP adherence (nights used) (ß = 1.04 (95% CI − 0.07 to 2.1); p = 0.07), and regular use (OR = 7.5 (95% CI 0.9–64.7); p = 0.07) after adjustment for ESS at baseline. After adjustment for ESS and days to cross over, SA by actual assignment did not show any effect on adherence variables. The ESS, ISI, FSS, and FOSQ-10 all showed significant improvements with PAP, but there were no differences in the magnitude of improvement in any score between groups.

Conclusions

Adherence to aPAP may be improved with the addition of SA and deserves further study. SA is as effective as standard aPAP for normalizing the AHI and improving sleep-related symptoms.

Clinical trial registration

ClinicalTrials.gov NCT02549508

https://clinicaltrials.gov/ct2/show/NCT02549508?term=NCT02549508&rank=1

“Comparison Study Using APAP With and Without SensAwake in Patients With OSA and PTSD”.

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Abbreviations

AASM:

American Academy of Sleep Medicine

AHI:

apnea–hypopnea index

CPAP:

continuous positive airway pressure

aPAP:

auto-PAP (auto-adjustable continuous positive airway pressure)

ESS:

Epworth Sleepiness Scale

FOSQ:

Functional Outcomes of Sleep Questionnaire

FSS:

Fatigue Severity Scale

ISI:

Insomnia Severity Index

ITT:

intention-to-treat analysis

OSA:

obstructive sleep apnea

PAP:

positive airway pressure

PCL:

PTSD checklist

PSG:

polysomnography

PTAF:

pressure transducer airflow

PTSD:

post-traumatic stress disorder

SA:

SensAwake™ (SA; Fisher and Paykel Healthcare, Auckland, New Zealand)

WRNMMC:

Walter Reed National Military Medical Center, Bethesda, MD

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Acknowledgments

All of the study authors contributed to the study and have reviewed the final manuscript. Dr. Holley conceived the research idea and performed statistical analysis and manuscript editing. Dr. Shaha contributed to data collection and analysis and assisted in the first draft of the manuscript. Mr. Terry contributed to patient recruitment, data collection, and data analysis. Dr. Costan-Toth contributed to data collection and data analysis. Dr. Slowik contributed to data collection and analysis. Dr. Robertson contributed to patient recruitment and data analysis. Dr. Williams contributed to patient recruitment and data collection. Ms. Golden contributed to patient recruitment, data collection, and analysis. Mr. Andrada contributed to data collection. Ms. Skeete contributed to patient recruitment and data collection. Ms. Sheikh contributed to patient recruitment and data collection. Mr. Butler contributed to data collection. Dr. Collen is the guarantor of the final article and is responsible for the integrity of the data and contents of this manuscript from study inception to publication of the final product.

Funding

This study was funded by Fisher-Paykel Healthcare (Grant #WR-GVA-FPH-10-32). This investigator-initiated project was conducted by using an unrestricted research grant and PAP machines provided by Fisher & Paykel Healthcare to the Geneva Foundation for the Advancement of Military Medicine. Fisher & Paykel Healthcare was involved with the study design, but not with patient enrollment, data collection and interpretation, manuscript preparation, or the decision to submit the manuscript for publication.

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Authors and Affiliations

  1. Walter Reed National Military Medical Center, 8901 Wisconsin Avenue, Bethesda, MD, 20889, USA

    Aaron Holley, Brian D. Robertson, Seth Terry, Dana Golden, Teotimo Andrada, Sonja Skeete, Karen Sheikh & George Butler

  2. Womack Army Medical Center, Fort Bragg, NC, USA

    David Shaha

  3. Fort Belvoir Community Hospital, Fort Belvoir, VA, USA

    Camille Costan-Toth & Scott G. Williams

  4. Madigan Army Medical Center, Tacoma, WA, USA

    Jennifer Slowik

  5. Uniformed Services University of the Health Sciences, 4301 Jones Bridge Road, Bethesda, MD, 20814, USA

    Jacob F. Collen

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  1. Aaron Holley
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Correspondence to Jacob F. Collen.

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Conflict of interest

None of the study authors have any relevant conflicts of interest to disclose.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

Statement and declarations

All authors have seen and approve the manuscript. This investigator-initiated project was conducted by using an unrestricted research grant and PAP machines provided by Fisher & Paykel Healthcare to the Geneva Foundation for the Advancement of Military Medicine. Fisher & Paykel Healthcare was involved with the study design, but not with patient enrollment, data collection and interpretation, manuscript preparation, or the decision to submit the manuscript for publication. The study authors have no other relevant disclosures.

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Electronic supplementary material

ESM 1

E-Table 1: Baseline description of study population (demographic and clinical characteristics) based on treatment received. E-Table 2: PAP adherence for aPAP with SA-ON and SA-OFF based on treatment received. Residual (Treated) “AHI” (PAP estimated residual respiratory disturbance index), measures of PAP leak, and minimum and maximum PAP pressures. 1. Overall percentage of nights PAP was used during the study (“Nights used (%)”). 2. Percent of nights with use greater than or equal to 4 h (“Nights ≥ 4 h (%)”). 3. Average hours of use per night, over total nights (“Hours/nights, total”). 4. Average hours of use per night, averaged only over the nights PAP was actually used (worn) (“Hours/nights, used”). 5. Regular use = ≥ 4 h for ≥ 70% of nights [57] (DOCX 16 kb)

ESM 2

E-Table 3: by treatment received. PAP adherence by treatment received, with adjustment for differences at baseline. 1. Average hours of use per night, averaged only over the nights PAP was actually used (worn) (“Hours/nights, used”). 2. Average hours of use per night, over total nights (“Hours/nights, total”). 3. Overall percentage of nights PAP was used during the study (“Nights used (%)”). 4. Percent of nights with use greater than or equal to 4 h (“Nights ≥ 4 h (%)”). 5. Regular use = ≥ 4 h for ≥ 70% of nights [57]. E-Table 4: Differences in sleep-related symptoms at 4 weeks by intention-to-treat and by treatment received. E-Table 5: Intra-patient comparisons for PAP adherence by treatment received. 1. Overall percentage of nights PAP was used during the study (“Nights used (%)”). 2. Percent of nights with use greater than or equal to 4 h (“Nights ≥ 4 h (%)”). 3. Average hours of use per night, over total nights (“Hours/nights, total”). 4. Average hours of use per night, averaged only over the nights PAP was actually used (worn) (“Hours/nights, used”) (DOCX 16 kb)

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Holley, A., Shaha, D., Costan-Toth, C. et al. A randomized, placebo-controlled trial using a novel PAP delivery platform to treat patients with OSA and comorbid PTSD. Sleep Breath 24, 1001–1009 (2020). https://doi.org/10.1007/s11325-019-01936-x

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