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Oxybutynin for Sleep Apnea

Phase 2

Recruiting

Led By Scott A Sands, PhD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one month

Awards & highlights

Study Summary

This trial is studying a combination of two drugs, atomoxetine and oxybutynin, to see if it improves sleep apnea severity and if patients exhibit signs of symptomatic relief.

Eligible Conditions

Sleep Apnea

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one month

This trial's timeline: 3 weeks for screening, Varies for treatment, and one month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Apnea-hypopnea index [AHI]

Secondary outcome measures

Arousal index

Epworth Sleepiness Scale

Functional Outcomes of Sleep Questionnaire, Short Form

+2 more

Side effects data

From 2008 Phase 4 trial • 57 Patients • NCT00224016

18%

Infection

18%

Headache

15%

Urinary tract infection

15%

Fever

13%

Pharyngitis

13%

Rash

13%

Vomiting

10%

Pain

10%

Constipation

Pain abdominal

Pruritis

Rhinitis

Diarrhea

Pain back

VP shunt malfunction

Skin ulcer

Gastritis

Knee wound dehiscence

Worsening dehydration

Tethered cord

100%

80%

60%

40%

20%

Study treatment Arm

Oxybutynin TDS

Oral Oxybutynin

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Atomoxetine and OxybutyninExperimental Treatment2 Interventions

Participants will take Atomoxetine and Oxybutynin nightly for one month. Half doses will be given on the first three nights.

Group II: PlaceboPlacebo Group1 Intervention

Participants will take Placebos nightly for one month. Half doses will be given on the first three nights.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atomoxetine

FDA approved

Oxybutynin

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,608 Previous Clinical Trials

11,469,802 Total Patients Enrolled

12 Trials studying Sleep Apnea

6,785 Patients Enrolled for Sleep Apnea

Scott A Sands, PhDPrincipal InvestigatorBrigham and Women's Hospital

6 Previous Clinical Trials

190 Total Patients Enrolled

1 Trials studying Sleep Apnea

23 Patients Enrolled for Sleep Apnea

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any additional trials to demonstrate the efficacy of Oxybutynin?

"Currently, 16 clinical trials examining Oxybutynin are active. Of these studies, 3 have advanced to Phase 3. While the main sites for research are in Almere and California; a total of 221 locations globally are running related experiments."

Answered by AI

Has the FDA sanctioned Oxybutynin for medical use?

"Despite the lack of efficacy data, a score of 2 was assigned to Oxybutynin in regards to safety based on its Phase 2 status."

Answered by AI

How many individuals are enrolled in the trial at present?

"Indeed, the information available on clinicaltrials.gov suggests this medical trial is seeking participants as of now. The posting date was September 3rd 2019 and the most recent update to the study took place in September 19th 2022. It targets 75 patients from a single site location."

Answered by AI

How is Oxybutynin commonly administered to treat medical conditions?

"Oxybutynin is a medication that has been employed to treat urinary urge incontinence, attention deficit hyperactivity disorder (ADHD), and various neurological disorders."

Answered by AI

What criteria would a person need to meet in order to join this clinical experiment?

"This sleep apnea trial is looking for 75 people that are between 21 to 70 years old. Additionally, it's imperative that all potential participants haven't been using CPAP therapy in the last month."

Answered by AI

Is enrollment for this research experiment still open?

"Affirmative. According to clinicaltrials.gov, this investigation is recruiting participants now; the trial was first posted on September 3rd 2019 and last updated on September 19th 2022. It has been estimated that 75 patients need to be enrolled from one location."

Answered by AI