CLINICAL TRIAL FS-007


CLINICAL TRIAL FS-007 • PRAGMATIC REAL-WORLD EFFECTIVENESS
CLINICAL TRIAL 7 / 7 • RESULTS

Trial FS-007 — Results

Trial ID FS-PILLOW-007 (NCT06340174)
Design Pragmatic open-label real-world effectiveness trial across 8 community sleep medicine practices
Population 130 adults with heterogeneous OSA presentations (mild to severe; including BMI ≥ 35, prior CPAP failure)
Duration 26 weeks of nightly use
Primary endpoint Adherence (% nights ≥ 6 h) and patient-reported outcomes at 26 weeks

Headline results

−53.2%
AHI Reduction
Across full real-world cohort
87.7%
Adherence Rate
Nights with ≥ 6 h use @ wk 26
91.5%
Would Recommend
Net Promoter Score = 78
9.0/10
Satisfaction
Mean treatment satisfaction

Primary and secondary outcomes (26 weeks, n = 130)

Outcome Baseline Week 26 Δ p-value
Total AHI (events/h) 24.8 ± 11.4 11.6 ± 6.8 −53.2% < 0.001
Supine AHI (events/h) 40.2 ± 14.1 13.4 ± 7.6 −66.7% < 0.001
ODI3% (events/h) 21.8 ± 10.3 10.4 ± 5.8 −52.3% < 0.001
SpO2 nadir (%) 83.7 ± 4.6 89.3 ± 3.2 +5.6 pp < 0.001
T90 (min) 26.4 ± 19.7 8.3 ± 7.4 −68.6% < 0.001
Snoring index (events/h) 298 ± 104 124 ± 71 −58.4% < 0.001
Epworth Sleepiness Scale 12.6 ± 3.5 7.2 ± 2.9 −5.4 < 0.001
Pittsburgh Sleep Quality Index 10.1 ± 2.7 5.6 ± 2.3 −4.5 < 0.001
FOSQ-10 12.9 ± 3.1 17.6 ± 2.5 +4.7 < 0.001
MoCA total 24.9 ± 2.4 27.1 ± 2.0 +2.2 < 0.001
Adherence (% nights ≥ 6 h) — 87.7% — —
Responder rate (≥ 50% ↓ AHI) — 69.2% — —
Therapeutic success (AHI < 5) — 40.8% — —
Treatment satisfaction (0–10) — 9.0 ± 1.2 — —
Would definitely recommend — 91.5% — —

Table 1. Primary and key secondary outcomes at 26 weeks, intention-to-treat. Values for continuous variables given as mean ± SD; pp = percentage points.

Subgroup analyses

Pre-specified subgroup analyses confirmed that the effect of FLORA SLEEP was consistent across age, sex, BMI, baseline severity, and prior treatment history:

Subgroup n Baseline AHI 26-wk AHI Δ % Adherence
Overall cohort 130 24.8 ± 11.4 11.6 ± 6.8 −53.2% 87.7%
Mild OSA (AHI 5–14.9) 38 11.2 ± 2.7 4.9 ± 2.4 −56.3% 90.3%
Moderate OSA (15–29.9) 57 21.4 ± 4.2 9.3 ± 4.1 −56.5% 88.6%
Severe OSA (≥ 30)* 35 40.6 ± 7.1 21.8 ± 8.4 −46.3% 83.4%
BMI < 25 24 18.4 ± 7.6 7.8 ± 4.0 −57.6% 92.1%
BMI 25–29.9 54 23.2 ± 9.8 10.4 ± 5.4 −55.2% 89.4%
BMI 30–34.9 38 27.8 ± 10.2 13.6 ± 7.1 −51.1% 84.7%
BMI ≥ 35* 14 34.1 ± 11.6 18.4 ± 8.2 −46.0% 79.3%
Age < 50 61 21.8 ± 9.4 9.6 ± 5.4 −56.0% 90.1%
Age 50–64 49 25.4 ± 11.8 11.7 ± 6.9 −54.0% 87.2%
Age ≥ 65 20 30.6 ± 12.4 15.7 ± 8.6 −48.7% 83.4%
Prior CPAP failure 47 23.8 ± 9.6 10.4 ± 5.7 −56.3% 88.4%
CPAP-naïve 83 25.2 ± 12.4 12.4 ± 7.4 −50.8% 87.4%
Female 54 21.8 ± 8.2 9.6 ± 4.6 −56.0% 90.7%
Male 76 26.9 ± 12.8 13.0 ± 7.6 −51.7% 85.6%

Table 2. Subgroup analyses at 26 weeks. *Severe OSA and BMI ≥ 35 strata enrolled exclusively as adjunctive therapy in patients otherwise managed with CPAP or oral appliance.

Safety and tolerability

Safety Endpoint Observed (n = 130)
Serious adverse events 0 (0.0%)
Withdrawals due to adverse event 0 (0.0%)
Mild cervical / shoulder discomfort (transient, week 1–2) 14 (10.8%)
Sleep-onset adjustment difficulty (week 1) 11 (8.5%)
Mild facial dermatitis (cover material) 1 (0.8%)
Need for size re-fitting 4 (3.1%)
Any treatment-related adverse event 18 (13.8%)

Table 3. Treatment-emergent adverse events at 26 weeks. All events were CTCAE grade 1, transient, and self-resolving.

Trial FS-007 confirms that the efficacy and adherence profile observed under controlled conditions (Trials FS-001 through FS-006) replicates faithfully in routine real-world clinical use across heterogeneous patient populations, including those with severe disease, high BMI, or prior CPAP failure.

Primary publication: Côté M-A, Tanaka R, Mehta P, et al. Annals of the American Thoracic Society. 2026;23(1):102–113.

— END OF RESULTS —
FLORA SLEEP Therapeutics, Inc.  |  Clinical Affairs Division
Document Version 4.2  |  May 2026  |  Confidential