Pitolisant improves depressive symptoms in CPAP-treated patients with obstructive sleep apnea and severe residual sleepiness: first clinical experience in a 12-month prospective pilot study

Pitolisant improves depressive symptoms in CPAP-treated patients with obstructive sleep apnea and severe residual sleepiness: first clinical experience in a 12-month prospective pilot study - PITOSA25

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00038339

Enrollment

Registered

2025-11-25

Start date

2024-01-01

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G47.3 G47.1 F32

Interventions

Group 1: Observational cohort: CPAP-treated OSA patients with severe residual excessive daytime sleepiness receiving Pitolisant in routine clinical practice. Patients were followed prospectively for 1

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Diagnosed obstructive sleep apnea with effective CPAP therapy (adequate AHI control) - Severe residual excessive daytime sleepiness despite CPAP - Presence of depressive symptoms at baseline - Age = 18 years - Ability to complete all planned follow-up visits - Written informed consent

Exclusion criteria

Exclusion criteria: - Narcolepsy (type 1 or type 2) - Idiopathic hypersomnia - Insufficient sleep syndrome - Shift-work sleep disorder or circadian rhythm sleep–wake disorders - Poor CPAP adherence (<4 h/night on average) - Untreated or unstable psychiatric disorders - Major depressive episode requiring immediate pharmacological adjustment - Severe cardiovascular or neurological diseases - Hypothyroidism or other endocrine disorders causing excessive sleepiness - Uncontrolled anemia or iron deficiency - Use of sedative medications affecting sleepiness (e.g., benzodiazepines, opioids, antipsychotics) - Alcohol or substance misuse - Pregnancy or breastfeeding - Known hypersensitivity to pitolisant

Design outcomes

Primary

Measure	Time frame
Primary outcomes: 1) Change in Epworth Sleepiness Scale (ESS) from baseline; 2) Change in Patient Health Questionnaire-9 (PHQ-9) from baseline. ESS and PHQ-9 were assessed at baseline and at 1, 3, 6, and 12 months using standardized questionnaires.	—

Secondary

Measure	Time frame
1) Changes in sleep-related symptoms and quality of life at 1, 3, 6, and 12 months. 2) Changes in CPAP adherence and device metrics across the 12-month follow-up. 3) Safety and tolerability of Pitolisant in routine clinical use.	—

Countries

Italy

Contacts

Public ContactLucia Spicuzza

Università degli Studi di Catania – Dipartimento di Medicina Clinica e Sperimentale

lucia.spicuzza@unict.it+393471491891

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026