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NCT Number: NCT05978505

Reboxetine for Sleep Apnoea After ENT Surgery

This pilot study will establish the feasibility of a larger trial to investigate whether reboxetine, a medication used to treat depression, can reduce the severity of obstructive sleep apnea (OSA) including increased blood oxygenation in post-surgical OSA patients where positive airway pressure (CPAP) therapy is either frequently poorly tolerated or not an option immediately post surgery. In this randomized, placebo-controlled, double-blind study, participants will use at-home sleep monitoring equipment before and after surgery plus measures of oxygenation. They will be prescribed either reboxetine or a placebo for seven days after surgery and complete questionnaires at the beginning and end of the study.

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 years
  • Undergoing elective upper airway surgery
  • History of obstructive sleep apnoea (OSA)

Exclusion criteria

  • Clinically significant cardiac disease (e.g., arrhythmia, coronary artery disease, or cardiac failure)
  • History of clinically significant urinary retention, bladder outlet obstruction, or benign prostatic hyperplasia
  • Poorly controlled hypertension
  • Epilepsy
  • History of schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-V or International Classification of Disease 10th edition criteria
  • History of attempted suicide or suicidal ideation within 1 year prior to screening, or current suicidal ideation
  • Narrow angle glaucoma

Treatment and study plan

Reboxetine 4 MG Oral Tablet

Drug

7 nightly doses (4mg) to commence after surgery.

Other names: Edronax

Placebo

Drug

7 nightly doses to commence after surgery.

Other names: Sugar pill

Primary outcomes

  1. Treatment protocol adherence

    Time frame: 7 days

    The percentage of total doses of the study drug (reboxetine or placebo) that were taken versus prescribed (assessed via pill counts) for this feasibility study.

  2. Data capture efficiency

    Time frame: 14 days

    The percentage of successful data collection nights versus missed nights of at-home oximetry for this feasibility study.

Secondary outcomes

  1. Oxygen desaturation index (ODI)

    Time frame: 14 days

    Number of times per hour that a participant has a drop in blood oxygen levels during sleep

  2. nadir SpO2

    Time frame: 14 days

    The lowest oxygen saturation value the patient drops to in a night.

  3. Time spent below 90% SpO2

    Time frame: 14 days

    The total amount of time per night for which oxygen saturation falls below 90%.

  4. mean SpO2

    Time frame: 14 days

    Average nightly oxygen level

  5. Sleep duration

    Time frame: 14 days

    Total amount of time spent asleep per night, sleep tracking performed using an under mattress sensor device.

  6. Sleep efficiency (%)

    Time frame: 14 days

    The estimated percentage of time in bed spent asleep performed using an under mattress sensor device.

  7. Daytime sleepiness

    Time frame: 14 days

    Measured via Karolinska Sleepiness Scale Questionnaire (9 point scale where 1 = extremely alert and 9 = extremely sleepy - fighting sleep)

  8. Perceived sleep quality measured via the Leeds Sleep Evaluation Questionnaire

    Time frame: 14 days

    This questionnaire asks participants to rate their perceived sleep across 4 domains on a visual analog scale as follows: 1) getting to sleep, 2) quality of sleep, 3) Awake following sleep, 4) Behavior following wakening. Higher scores indicate better perceived sleep.

  9. Insomnia Severity Score

    Time frame: 14 days

    A patient-reported measure of insomnia symptoms using the Insomnia Severity Index- A 28 point scale where 0 indicates no clinically significant insomnia and 28 indicates maximally severe clinical insomnia.

  10. Apnoea-hypopnea hndex (AHI)

    Time frame: 14 days

    Change in OSA severity (AHI estimated via the Withings under mattress sensor number of events/hour) between placebo and reboxetine

  11. Study enrolment rate

    Time frame: 12 months

    The number of referred patients successfully enrolled into this feasibility study

Other outcomes

  1. Reboxetine-related side effects

    Time frame: 14 days

    Documented via adverse-event forms.

Study contacts

Contact information is provided by the study sponsor or research team.

Carolin Tran

CONTACT

[email protected]

+61874219873

Emma Thomas

CONTACT

[email protected]

+61882012912

Sponsors and collaborators

Lead sponsor

Flinders University

Other

Collaborators

  • Flinders Medical Centre

Registry information

Official study title

Reboxetine for Obstructive Sleep Apnoea After Upper Airway Surgery: a Randomised, Double-blind, Placebo-controlled Study

Acronym: RENTOSA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2023
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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