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

Sleep. 2024 May 10;47(5):zsae044. doi: 10.1093/sleep/zsae044.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adult
  • Behavior Therapy / methods
  • Continuous Positive Airway Pressure / methods
  • Female
  • Humans
  • Male
  • Middle Aged
  • Patient Education as Topic / methods
  • Sleep Apnea Syndromes* / complications
  • Sleep Apnea Syndromes* / therapy
  • Sleep Quality
  • Spinal Cord Injuries* / complications
  • Spinal Cord Injuries* / therapy
  • Treatment Outcome
  • Veterans* / statistics & numerical data

Associated data

  • ClinicalTrials.gov/NCT02830074