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Randomized Controlled Trial
. 2024 May 10;47(5):zsae044.
doi: 10.1093/sleep/zsae044.

Intensive support does not improve positive-airway pressure use in spinal cord injury/disease: a randomized clinical trial

M Safwan Badr  1   2 , Jennifer L Martin  3   4 , Abdulghani Sankari  1   2   5 , Salam Zeineddine  1   2 , Anan Salloum  1   2 , M Kristina Henzel  4   6 , Kingman Strohl  6 , Afifa Shamim-Uzzaman  7   8 , Anna M May  6 , Constance H Fung  3   4 , Nishtha Pandya  1   2 , Sean Carroll  1   2 , Michael N Mitchell  4
Affiliations
Randomized Controlled Trial

Intensive support does not improve positive-airway pressure use in spinal cord injury/disease: a randomized clinical trial

M Safwan Badr et al. Sleep. .

Abstract

Study objective: Treatment of sleep-disordered breathing (SDB) with positive airway pressure (PAP) therapy has unique clinical challenges in individuals living with spinal cord injuries and diseases (spinal cord injury [SCI]/D). Interventions focused on increasing PAP use have not been studied in this population. We aimed to evaluate the benefits of a program to increase PAP use among Veterans with SCI/D and SDB.

Methods: Randomized controlled trial comparing a behavioral Intervention (n = 32) and educational control (n = 31), both including one face-to-face and five telephone sessions over 3 months. The intervention included education about SDB and PAP, goal setting, troubleshooting, and motivational enhancement. The control arm included non-directive sleep education only.

Results: Primary outcomes were objective PAP use (nights ≥4 hours used within 90 days) and sleep quality (Pittsburgh Sleep Quality Index [PSQI] at 3 months). These did not differ between intervention and control (main outcome timepoint; mean difference 3.5 [-9.0, 15.9] nights/week for PAP use; p = .578; -1.1 [-2.8, 0.6] points for PSQI; p = .219). Secondary outcomes included fatigue, depression, function, and quality of life. Only fatigue improved significantly more in the intervention versus the control group (p = .025). Across groups, more PAP use was associated with larger improvements in sleep quality, insomnia, sleepiness, fatigue, and depression at some time points.

Conclusions: PAP use in Veterans with SCI/D and SDB is low, and a 3-month supportive/behavioral program did not show significant benefit compared to education alone. Overall, more PAP use was associated with improved symptoms suggesting more intensive support, such as in-home assistance, may be required to increase PAP use in these patients.

Clinical trials information: Title: "Treatment of Sleep Disordered Breathing in Patients with SCI." Registration number: NCT02830074. Website: https://clinicaltrials.gov/study/NCT02830074?cond=Sleep%20Apnea&term=badr&rank=5.

Keywords: adherence; positive-airway pressure therapy; sleep-disordered breathing; spinal cord injury.

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Figures

Graphical Abstract
Graphical Abstract
Figure 1.
Figure 1.
CONSORT diagram depicting participant flow through the study from screening through follow-up. AHI, apnea–hypopnea index; PAP, positive-airway pressure; SCI/D, Spinal cord injury or disease.
Figure 2.
Figure 2.
Monthly PAP use data for intervention (BEST) and control groups shown as marginal mean number of nights used out of 30 nights per month (primary outcome). There were no significant differences between groups at any time point. PAP, positive-airway pressure.
Figure 3.
Figure 3.
Marginal means of Pittsburgh Sleep Quality Index scores (with 95% CI) by intervention group and time.
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