Radiofrequency treatment of turbinate hypertrophy in subjects using continuous positive airway pressure: a randomized, double-blind, placebo-controlled clinical pilot trial.

The Laryngoscope · 2001 · Mixed · Low evidence

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MixedLow evidencePaper 3921

Study snapshot

PublicationThe Laryngoscope · 2001

Study typerandomized_trial

Reported directionMixed

Evidence ratingLow

Abstract

OBJECTIVES: To estimate the treatment effect of temperature-controlled radiofrequency (TCRF) reduction of turbinate hypertrophy in patients with sleep-disordered breathing (SDB) treated with nasal continuous positive airway pressure (CPAP), and to assess the impact of study design on this estimate. STUDY DESIGN: Prospective, randomized, double-blind, placebo-controlled clinical pilot trial. METHODS: Twenty-two CPAP-treated patients with SDB with turbinate hypertrophy were randomly assigned to either TCRF turbinate treatment (mean energy 415 +/- 37 J/turbinate; n = 17) or placebo control (n = 5). Changes in nasal obstruction were evaluated between pretreatment and 4 weeks post-treatment. The primary outcome assessed changes in the blinded examiners' findings of nasal obstruction on a visual analogue scale (VAS). Secondary outcomes included blinded patients' and unblinded examiner assessments of nasal obstruction (VAS), nightly CPAP use, adherence, and tolerance, along with sleepiness and general health status scales. The treatment group findings were subtracted from the changes in the placebo group to yield treatment effect. RESULTS: The primary outcome treatment effect by VAS was -0.9 cm (95% confidence interval [CI], -2.4, 0.7), and beyond the placebo effect of -1.5 cm (95% CI: -3.4, 0.3). The secondary treatment effect of the unblinded examiner was -3.0 cm (95% CI, -4.9, -1.1). A beneficial treatment effect was also seen on every secondary outcome except general health status, but only self-reported CPAP adherence (P = .03) was statistically significant. CONCLUSIONS: TCRF turbinate treatment appears to benefit nasal obstruction and CPAP treatment for SDB. Placebo control and double blinding are critical for establishing the true treatment effect. A future definitive trial is feasible to establish statistical significance of these findings.

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AI evidence extraction

Structured fields below were generated from the paper’s abstract and metadata to make the evidence easier to inspect. Automated extraction may be incomplete or incorrect; verify important details against the original paper.

Study typerandomized_trial

Effect directionmixed

PopulationCPAP-treated patients with sleep-disordered breathing (SDB) with turbinate hypertrophy

Sample size22

ExposureRF

Evidence strengthLowConfidence: 74% · Peer reviewed: yes

Main findings

In 22 CPAP-treated SDB patients with turbinate hypertrophy randomized to TCRF (n=17) vs placebo (n=5), the primary blinded-examiner VAS treatment effect for nasal obstruction at 4 weeks was -0.9 cm (95% CI -2.4 to 0.7). The unblinded examiner secondary outcome showed a larger treatment effect (-3.0 cm; 95% CI -4.9 to -1.1). Beneficial effects were reported for all secondary outcomes except general health status, but only self-reported CPAP adherence was statistically significant (P=.03).

Outcomes measured

Nasal obstruction (visual analogue scale; blinded examiner primary outcome)
Nasal obstruction (VAS; blinded patient)
Nasal obstruction (VAS; unblinded examiner)
Nightly CPAP use
CPAP adherence
CPAP tolerance
Sleepiness scale(s)
General health status scale(s)

Limitations

Pilot trial with small sample size (n=22) and unequal group sizes (17 vs 5)
Primary outcome confidence interval includes no effect
Short follow-up (4 weeks)
Some outcomes assessed by an unblinded examiner

View raw extracted JSON

{
  "study_type": "randomized_trial",
  "exposure": {
    "band": "RF",
    "source": "medical device (temperature-controlled radiofrequency turbinate reduction)",
    "frequency_mhz": null,
    "sar_wkg": null,
    "duration": null
  },
  "population": "CPAP-treated patients with sleep-disordered breathing (SDB) with turbinate hypertrophy",
  "sample_size": 22,
  "outcomes": [
    "Nasal obstruction (visual analogue scale; blinded examiner primary outcome)",
    "Nasal obstruction (VAS; blinded patient)",
    "Nasal obstruction (VAS; unblinded examiner)",
    "Nightly CPAP use",
    "CPAP adherence",
    "CPAP tolerance",
    "Sleepiness scale(s)",
    "General health status scale(s)"
  ],
  "main_findings": "In 22 CPAP-treated SDB patients with turbinate hypertrophy randomized to TCRF (n=17) vs placebo (n=5), the primary blinded-examiner VAS treatment effect for nasal obstruction at 4 weeks was -0.9 cm (95% CI -2.4 to 0.7). The unblinded examiner secondary outcome showed a larger treatment effect (-3.0 cm; 95% CI -4.9 to -1.1). Beneficial effects were reported for all secondary outcomes except general health status, but only self-reported CPAP adherence was statistically significant (P=.03).",
  "effect_direction": "mixed",
  "limitations": [
    "Pilot trial with small sample size (n=22) and unequal group sizes (17 vs 5)",
    "Primary outcome confidence interval includes no effect",
    "Short follow-up (4 weeks)",
    "Some outcomes assessed by an unblinded examiner"
  ],
  "evidence_strength": "low",
  "confidence": 0.74,
  "peer_reviewed_likely": "yes",
  "keywords": [
    "temperature-controlled radiofrequency",
    "turbinate hypertrophy",
    "nasal obstruction",
    "CPAP",
    "sleep-disordered breathing",
    "randomized",
    "double-blind",
    "placebo-controlled"
  ],
  "suggested_hubs": []
}

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AI-extracted fields are generated from the abstract and metadata and may be incomplete or incorrect. This material is for informational purposes and is not medical advice.

Identifiers and source

DOI: 10.1097/00005537-200110000-00023
PubMed: 11801946

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