Comparison of Temazepam and Acetazolamide to Treat Difficulty Sleeping at High Altitude

NCT01519544 | Completed

• 1 other identifier: 2012P000017
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

More than 70% of visitors to high altitude suffer poor sleep. The present study seeks to answer the question: Which medication is associated with better sleep at high altitude: temazepam or acetazolamide? The investigators hypothesis is that one medication will be associated with higher subjective sleep scores than the other. The study will compare the sleep quality of 100 subjects as they take either temazepam or acetazolamide during a visit to high altitude.

Conditions

High-altitude Sleep Disturbance

Keywords

Sleep; High Altitude; High-altitude Sleep Disturbance; Acute Mountain Sickness; Difficulty Sleeping at High Altitude; Periodic Breathing; Actigraphy; Acetazolamide; Temazepam; Groningen Sleep Quality Questionnaire survey; Stanford Sleepiness Scale; Lake Louise Acute Mountain Sickness Score

Outcome Measures

Primary Outcomes (2)

• Global assessment of sleep quality using a 100mm visual analog scale

  The morning after taking the study medication, subjects will be asked: How would you rate last night's sleep quality? They will mark their answer on a 100mm visual analog scale with 0mm representing 'worst night of sleep ever' and 100mm representing 'best night of sleep ever'.

  1 day

• The Groningen Sleep Quality Questionnaire survey

  The Groningen Sleep Quality Questionnaire survey includes fifteen questions that describe sleep onset, sleep quality, awakenings, sleep duration, and wake up quality. Survey is completed by the subject.

  1 day

Secondary Outcomes (16)

• Sleep Onset Latency

  1 day

• Total Sleep Duration

  1 day

• Time in Bed

  1 day

• Number of Awakenings

  1 day

• Number of Awakenings to Urinate

  1 day

Study Arms (2)

Temazepam

ACTIVE COMPARATOR

50 subjects are instructed to take 7.5mg temazepam by mouth prior to going to sleep for one night only.

Drug: Temazepam

Acetazolamide

ACTIVE COMPARATOR

50 subjects are instructed to take 125mg of acetazolamide by mouth prior to going to sleep one night only.

Drug: Acetazolamide

Interventions

Temazepam DRUG

Temazepam 7.5mg capsule to be taken by mouth at bedtime for one night only.

Also known as: Restoril

Temazepam

Acetazolamide DRUG

Take Acetazolamide 125mg tablet by mouth at bedtime for one night only.

Also known as: Diamox

Acetazolamide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Trekkers on the Annapurna circuit
• Must be in the process of ascent (\> 200 meters over the previous 24 hours)
• Must be willing to stay 2 nights in Manang, Nepal
• Healthy adults, age 18-65
• Self-report of new difficulty sleeping over the previous two days

You may not qualify if:

• Recent (\< 2 weeks) high altitude exposure (higher than 11, 500 feet or 3500 meters)
• Current acute illness
• Moderate to Severe Acute Mountain Sickness (Lake Louise AMS score \> 4)
• High Altitude Cerebral Edema
• High Altitude Pulmonary Edema
• Any pre-existing sleep disorders or sleep related condition including obstructive sleep apnea, morbid obesity (BMI \> 40), restless leg syndrome, etc.
• Any lung disease or condition affecting the lungs, including chronic obstructive pulmonary disease, asthma, cystic fibrosis, etc.
• Congestive heart failure, pulmonary hypertension, or cardiomyopathy
• Current oxygen use
• Kidney disease
• Liver disease
• Pregnancy or breast feeding
• Seizure disorder or other neurologic disorder
• Glaucoma
• Sulfa allergy

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Himalayan Rescue Location clinic in Manang

Manang, District of Manang, 33500, Nepal

Location

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MeSH Terms

Conditions

Altitude Sickness

Interventions

Temazepam; Acetazolamide

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Norman S Harris, MD, MFA

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, MGH Wilderness Medicine Fellowship; Chief, Division of Wilderness Medicine, Department of Emergency Medicine, Massachusetts General Hospital; Assistant Professor of Surgery, Harvard Medical School

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: January 27, 2012
• Study Start: March 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: March 1, 2015
• Last Updated: April 23, 2015

Record last verified: 2015-04

Locations

NE (1)