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Efficacy of Nortriptyline in treating OSA

Efficacy of Nortriptyline in treating OSA: Randomized, placebo-controlled, double-blind clinical trial.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240407061441N1
Enrollment
24
Registered
2024-04-18
Start date
2024-04-13
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Obstructive Sleep Apnea. Obstructive sleep apnea (adult) (pediatric)

Interventions

Intervention 1: Intervention group: Patients are treated with Nortriptyline 25 mg for one month, and then undergo polysomnography. Intervention 2: Control group: Patients are treated with a placebo f

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: =18 years of age at the time of informed consent PSG criteria: AHI of >5; = 25% central or mixed apneas; and PLM arousal index =15 Escale of sleepiness symptom score =10 PAP intolerance or current PAP refusal BMI between 18.5 and 30 kg/m2 for men, or 32 kg/m2 for women

Exclusion criteria

Exclusion criteria: Narcolepsy, restless leg syndrome, REM sleep behavior disorder Insomnia disorder or use of sedative-hypnotics or other medication to treat or avoid insomnia symptoms, shift disorder or night shift craniofacial malformation syndrome, or grade =3 tonsillar hypertrophy Clinically significant cardiac disease, e.g., ventricular arrhythmia, untreated or unstable coronary artery disease, cardiac failure Metabolic, renal, pulmonary disease, and uncontrolled HTN Neuromuscular disorder (e.g., motor neuron disease, muscular dystrophy or myopathy, myasthenic syndrome); epilepsy; Parkinson's, Alzheimer's, or another neurodegenerative disease Central neural system stimulant or suppressant drugs

Design outcomes

Primary

MeasureTime frame
Apnea-Hypopnea Index. Timepoint: after one month of medication consumption. Method of measurement: Polysomnography.;Sleepiness Scale. Timepoint: after one month of medication consumption. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFateme Mohammadi

Shahid Beheshti University of Medical Sciences

fatemeh.Mohammadi.inloo@gmail.com+98 21 2712 3816

Outcome results

None listed

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