Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00211614
Other study ID # IRB04-00029
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date July 2006
Est. completion date September 2006

Study information

Verified date December 2018
Source MetroHealth Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Obstructive Sleep Apnea (OSA) is common in modern society, affecting up to 5% of working middle-aged adults in the United States. Obesity is the number one risk factor for the development of OSA. Consequences of untreated OSA are varied and significant and included numerous neuropsychiatric parameters such as mood alterations, depression, anxiety, diminished social interactions, and decreased quality of life. Mounting evidence suggests that treatment of OSA can improve many of these outcomes. The primary treatment modality for this condition is continuous positive airway pressure (CPAP). This device delivers positive pressure to the upper airway in order to prevent its collapse during sleep. Unfortunately, many patients do not choose to use CPAP or have difficulty with these devices. This results in many individuals with OSA either going without therapy or unable to reap the full benefits of treatment.

Gastroesophageal reflux (GERD) is also common in the United States and may, in some instances, be directly related to weight gain. Survey studies have suggested that symptomatic GERD is more common in patients with OSA. Whether there exists a cause and effect relationship between these two conditions is not known at present. It has been suggested that GERD may contribute to OSA by narrowing the upper airway.

This study will examine the effect of treatment of GERD on mild to moderate OSA. Fifty individuals identified as having mild to moderate OSA (diagnosed by overnight sleep study or PSG) and GERD (confirmed by an esophageal probe) will be enrolled. Both men and women will be included in this study and no "special populations" will be utilized. Subjects will fill out questionnaires to subjectively measure sleepiness, OSA-related symptoms, GERD-related symptoms, and sleep apnea-related quality of life. They will then be randomized to receive either 12 weeks of the proton pump inhibitor lansoprazole (Prevacid) or placebo (twenty five subjects per group). Upon completion of the 12 week trial, subjects will return and the following data will be collected; repeat all of the baseline questionnaires, repeat PSG and repeat pH probe.

Results from this study will help to establish the relative effectiveness of a novel form of therapy for a common yet difficult to manage medical condition. . The risks to subjects enrolled in the study are minimal and therefore the benefit to risk ratio is heavily in favor of performing the study.


Description:

See above.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2006
Est. primary completion date September 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Adults (> 18 years old) with mild to moderate OSA (as defined by an apnea-hypopnea index between 5 and 30) currently on no therapy.

2. GERD as documented by 24 pH probe (> 6% of the time with pH < 4).

3. Agreeable to participating in the study

Exclusion Criteria:

1. Those not meeting the inclusion criteria

2. Prisoners, minors, incompetent subjects, unconscious subjects, house staff and students, pregnant women

3. Oxygen dependent, requiring supplemental oxygen during sleep, or significant hypoxia during the initial PSG (O2 sats < 85% for > 5 minutes of sleep)

4. Severe cardiac or pulmonary disease (CHF with EF < 40%, active coronary ischemia or unstable angina, uncontrolled arrythmias,COPD or other lung condition requiring supplemental oxygen or documented hypercapnia of a pCO2 > 45).

5. Neuromuscular disease with hypercapnia (pCO2 > 45)

6. Any cancer with a prognosis of < 1 year survival

7. Use of H2 blocker therapy or PPI therapy within 14 days of the initial PSG.

8. Individuals requiring routine use of sleep aids (i.e. benzodiazepines or other sedatives)

9. Individuals with active alcohol or substance abuse

10. Night shift workers or those working rotating shifts

11. Disabling sleepiness (Epworth Sleepiness Scale > 17 or history of accidents related to sleepiness) that places individual at risk for accidents.

12. Inability to complete study questionnaires

13. Allergy to lansoprazole

Study Design


Intervention

Drug:
Lansoprazole


Locations

Country Name City State
United States MetroHealth Medical Center Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
MetroHealth Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction in the apnea-hypopnea index
Secondary Numerous sleep parameters (arousals, sleep efficiency, sleep architecture), daytime sleepiness, GERD sxs, QOL measures
See also
  Status Clinical Trial Phase
Recruiting NCT05857384 - Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs Phase 1
Recruiting NCT04547543 - Follow-up of Apneic Patients by Visio-consultation N/A
Recruiting NCT05371509 - Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study N/A
Completed NCT02515357 - Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea N/A
Completed NCT05582070 - Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction N/A
Active, not recruiting NCT03189173 - Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea Phase 2
Completed NCT04084899 - The Effect of CPAP on Lung Hyperinflation in Patients With OSA
Completed NCT03032029 - Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
Recruiting NCT04028011 - Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
Recruiting NCT06047353 - Community Health Advocates for Motivating PAP Use in Our Neighborhoods. N/A
Completed NCT05253963 - Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea N/A
Recruiting NCT06029959 - Stroke and CPAP Outcome Study 3 N/A
Recruiting NCT06150352 - Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
Completed NCT03589417 - Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
Recruiting NCT04335994 - ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing N/A
Withdrawn NCT04063436 - Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea N/A
Recruiting NCT05385302 - Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
Recruiting NCT04572269 - Metabolomics of Obstructive Sleep Apnea
Not yet recruiting NCT06467682 - 12-week Tele-exercise Program in Patients With OSA N/A
Withdrawn NCT04011358 - Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study N/A